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 .
This Office Action is in response to the amendments dated December 1, 2025.
Claims 1-16 are pending.
Claim Objections
Claim 15 is objected to because of the following informalities: line 2 removes the term “main” when describing the controller, in order to overcome the previously presented rejection of Claim 15 under 35 U.S.C. 112(b). However, Claim 15 is labeled as (Original) instead of (Currently Amended). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. More specifically, Claims 1 and 10 claim “running self-check of the reprocessing device at every reprocessing operation”. It is unclear if the self-check is performed during the steps of performing “a flow test during which one of pressures or pressure differences are checked in a sequence of application and blocking of the fluid in the one or more endoscope channels connected to the reprocessing device for identification of anomalies occurring at the one or more individual endoscope channels”, or during some other unspecified reprocessing operation. It is also unclear if the self-checking is performed while the reprocessing device is reprocessing a same endoscope at subsequent times, or different endoscopes at different times. For purposes of examination, the term “running self-check of the reprocessing device at every reprocessing operation” is interpreted as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device. This interpretation is made in light of paragraph [0016] of the present specification, “Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device”.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art.
Claims 1-2, 8, and 10-12 are rejected under 35 U.S.C. 102(a)(a) as being anticipated by Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”).
With regard to Claim 1, Nguyen discloses:
A method for self-checking of an endoscope reprocessing device (Nguyen FIG. 1, endoscope reprocessor 100) having at least one source for a fluid (Nguyen FIG. 3, fluid pump 162 and manifold 166 within channel flow subsystem 160), one or more supply channels (Nguyen FIG. 3, supply lines 164) for supplying the fluid from the at least one source to one or more individual endoscope channels of one or more endoscopes connected with the one or more supply channels (Nguyen paragraph [0041], “endoscope reprocessor can comprise a channel flow subsystem 160 including a manifold 166 in fluid communication with the circulation system pump, indicated as pump 162, which can be configured to distribute the pressurized fluid to the channel supply lines of the endoscope reprocessor and then to the channels of the endoscope”), and a controller for controlling the reprocessing of endoscopes (Nguyen paragraph [0007], “a processor in signal communication with the linear sensor, wherein the processor is configured to operate the supply pump” in the endoscope reprocessor), each of the one or more supply channels having a dedicated switchable valve (Nguyen FIG. 3, valves 174; Nguyen paragraph [0041], “each endoscope reprocessor supply line 164 can include at least one differential pressure sensor 172, at least one proportional valve 174, and at least one gage pressure sensor 176”) configured to let through the fluid and to block the supply channel in response to a control signal issued by the controller (Nguyen paragraph [0009], “the processor is configured to…command the valve to at least one of at least partially close and at least partially open”), the method comprising:
reprocessing the one or more endoscopes connected to the reprocessing device, the reprocessing of the one or more endoscopes comprising a flow test during which one of pressures or pressure differences are checked in a sequence of application and blocking of the fluid in the one or more endoscope channels connected to the reprocessing device for identification of anomalies occurring at the one or more individual endoscope channels (Nguyen paragraph [0038], “the endoscope reprocessor 100 can include a circulation system which can circulate one or more reprocessing fluids such as detergent, sterilant, disinfectant, water, alcohol, and/or any other suitable fluid, for example, through the endoscope and/or spray the fluid onto the endoscope.” Examiner interprets initiating the circulation of fluid through the endoscope as a sequence of application (starting) and blocking (ending) the fluid. See also Nguyen paragraph [0040], which describes monitoring fluid flow rates.); and
carrying out a running self-check of the reprocessing device at every reprocessing operation, the running self-check comprising keeping a history of flow test results, updating the history with latest flow test results and carrying out an analysis of the history of flow test results for each of the one or more supply channels of the reprocessing device (Nguyen paragraph 0043], “a plurality of fluid flow rate values can be stored in a look-up table defined within programmable memory on the PCB assembly 179…the values can be empirically tested and then stored in the programmable memory. In either event, the fluid flow rate can be determined as a function of the gauge pressure of the fluid being discharged by the circulation pump 162 and supplied to the manifold 166. In at least one such embodiment, a gauge pressure sensor, such as gauge pressure sensor 159 (FIG. 3), for example, can be positioned downstream with respect to the outlet of the circulation pump 162 such that the gauge pressure of the fluid being supplied to each of the reprocessor channel supply lines 164 can be measured. ” Examiner interprets carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device, as disclosed by Nguyen presented above. This interpretation is made in light of paragraph [0016] of the present specification, “Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device.”); and
indicating a problem with one of a supply channel of the one or more supply channels or a valve associated with the supply channel if the history of flow test results contains one or more flow test result anomalies in the supply channel that meet at least one or more predefined criteria (Nguyen paragraph [0046], “In the event that the actual flow rate of the fluid through the reprocessor supply line 164 is below the minimum acceptable value or above the maximum acceptable value stored in the look-up table for a given gauge pressure for a given reprocessor supply line 164, the PCB assembly 179 may open, partially open, close, and/or partially close the proportional valve 174 associated therewith.”).
With regard to Claim 2, Nguyen discloses the features of Claim 1, as described above.
Nguyen further discloses wherein the one or more flow test result anomalies is a blockage of an endoscope channel (Nguyen paragraph [0040], “channels defined within the endoscope can be become blocked or obstructed by debris, for example, which can inhibit the endoscope from being properly cleaned, disinfected, and/or sterilized. In some circumstances, the debris positioned within an endoscope channel can at least partially block the flow of the fluid therethrough thereby reducing the rate in which the fluid can flow through the channel.” Examiner interprets this as disclosing a reason/fault responsible for creating a reduced flow, as described within Nguyen”) connected with the supply channel or a problem with the attachment of an endoscope channel to the supply channel.
With regard to Claim 8, Nguyen discloses the features of Claim 1, as described above.
Nguyen further discloses wherein the flow tests of endoscope channels connected with the one or more supply channels are performed sequentially one after another or in several or all of the one or more supply channels in parallel at least one of before, during and after reprocessing of an endoscope (Nguyen paragraph [0069], “the devices and methods described herein can be designed to provide an adequate supply of reprocessing fluid to clean, disinfect, and/or sterilize an endoscope”. Examiner interprets the flow tests described above Nguyen paragraph [0038] as being the same process as the reprocessing of the endoscope.).
With regard to Claim 10, Nguyen discloses:
An endoscope reprocessing device (Nguyen FIG. 1, endoscope reprocessor 100) comprising:
a washing cabinet (Nguyen FIG. 1, reprocessor frame 140) configured to receive one or more endoscopes (Nguyen FIG. 17, endoscope 101) to be reprocessed;
a controller (Nguyen FIG. 9, PCB assembly 179; Nguyen paragraph [0047], “the microprocessor of the PCB assembly 179 can be configured to adjust the position of the valve element within the valve chamber 180 of the proportional valve 174”);
at least one source for a fluid (Nguyen FIG. 3, fluid pump 162 and manifold 166 within channel flow subsystem 160) controlled by the controller; and
one or more supply channels (Nguyen FIG. 3, supply lines 164) connecting the at least one source for fluid to the washing cabinet (Nguyen paragraph [0041], “endoscope reprocessor can comprise a channel flow subsystem 160 including a manifold 166 in fluid communication with the circulation system pump, indicated as pump 162, which can be configured to distribute the pressurized fluid to the channel supply lines of the endoscope reprocessor and then to the channels of the endoscope”, each of the one or more supply channels having an electronically controlled valve (Nguyen FIG. 3, valves 174) for opening and closing a respective supply channel and each of the one or more supply channels having a pressure sensor (Nguyen FIG. 3 pressure sensors 176) connected to the respective supply channel downstream of the valve;
wherein the controller is configured to:
carry out a running self-check of the reprocessing device at every endoscope reprocessing operation, the running self-check comprising keeping a history of flow test results, updating the history with latest flow test results and carrying out an analysis of the history of flow test results for each of the one or more supply channels (Nguyen paragraph 0043], “a plurality of fluid flow rate values can be stored in a look-up table defined within programmable memory on the PCB assembly 179…the values can be empirically tested and then stored in the programmable memory. In either event, the fluid flow rate can be determined as a function of the gauge pressure of the fluid being discharged by the circulation pump 162 and supplied to the manifold 166. In at least one such embodiment, a gauge pressure sensor, such as gauge pressure sensor 159 (FIG. 3), for example, can be positioned downstream with respect to the outlet of the circulation pump 162 such that the gauge pressure of the fluid being supplied to each of the reprocessor channel supply lines 164 can be measured. ” Examiner interprets the controller configured to carry out a running self-check of the reprocessing device at every endoscope reprocessing operation as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device, as disclosed by Nguyen presented above. This interpretation is made in light of paragraph [0016] of the present specification, “Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device.”), and
indicating a problem with a supply channel of the one or more supply channels or a valve associated with the supply channel if the history of flow test results contains one or more flow test result anomalies in the supply channel that meet at least one or more predefined criteria (Nguyen paragraph [0046], “In the event that the actual flow rate of the fluid through the reprocessor supply line 164 is below the minimum acceptable value or above the maximum acceptable value stored in the look-up table for a given gauge pressure for a given reprocessor supply line 164, the PCB assembly 179 may open, partially open, close, and/or partially close the proportional valve 174 associated therewith.”).
With regard to Claim 11, Nguyen discloses the features of Claim 10, as described above.
Nguyen further discloses wherein the at least one source for fluid is connected via a switchable valve (Nguyen FIG. 3, valve 167) to a common bus channel (Nguyen manifold 166) from which the one or more supply channels branch off.
With regard to Claim 12, Nguyen discloses the features of Claim 11, as described above.
Nguyen further discloses wherein the at least one source for fluid comprises a reprocessing fluid supply (Nguyen FIG. 3, water pump 162) and pressurized air supply (Nguyen FIG. 3, pressurized air source 190), the switchable valve has two positions for alternatively letting through the reprocessing fluid and the pressurized air (Nguyen paragraph [0051], “he endoscope reprocessor 100 can comprise one or more valves, such as valve 167, for example, which can be operated to permit a flow of pressurized air from a pressurized air source 190, for example, into the manifold 166. In at least one such embodiment, the pressurized air can force any remaining water, detergent, and/or sterilant out of the endoscope channels.”).
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.
Claims 1-2, 8, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”).
Regarding Claim 1, Nguyen discloses:
A method for self-checking of an endoscope reprocessing device (Nguyen FIG. 1, endoscope reprocessor 100) having at least one source for a fluid (Nguyen FIG. 3, fluid pump 162 and manifold 166 within channel flow subsystem 160), one or more supply channels (Nguyen FIG. 3, supply lines 164) for supplying the fluid from the at least one source to one or more individual endoscope channels of one or more endoscopes connected with the one or more supply channels (Nguyen paragraph [0041], “endoscope reprocessor can comprise a channel flow subsystem 160 including a manifold 166 in fluid communication with the circulation system pump, indicated as pump 162, which can be configured to distribute the pressurized fluid to the channel supply lines of the endoscope reprocessor and then to the channels of the endoscope”), and a controller for controlling the reprocessing of endoscopes (Nguyen paragraph [0007], “a processor in signal communication with the linear sensor, wherein the processor is configured to operate the supply pump” in the endoscope reprocessor), each of the one or more supply channels having a dedicated switchable valve (Nguyen FIG. 3, valves 174; Nguyen paragraph [0041], “each endoscope reprocessor supply line 164 can include at least one differential pressure sensor 172, at least one proportional valve 174, and at least one gage pressure sensor 176”) configured to let through the fluid and to block the supply channel in response to a control signal issued by the controller (Nguyen paragraph [0009], “the processor is configured to…command the valve to at least one of at least partially close and at least partially open”), the method comprising:
reprocessing the one or more endoscopes connected to the reprocessing device, the reprocessing of the one or more endoscopes comprising a flow test during which one of pressures or pressure differences are checked in a sequence of application and blocking of the fluid in the one or more endoscope channels connected to the reprocessing device for identification of anomalies occurring at the one or more individual endoscope channels (Nguyen paragraph [0038], “the endoscope reprocessor 100 can include a circulation system which can circulate one or more reprocessing fluids such as detergent, sterilant, disinfectant, water, alcohol, and/or any other suitable fluid, for example, through the endoscope and/or spray the fluid onto the endoscope.” Examiner interprets initiating the circulation of fluid through the endoscope as a sequence of application (starting) and blocking (ending) the fluid. See also Nguyen paragraph [0040], which describes monitoring fluid flow rates.); and
carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation, the running self-check comprising keeping a history of flow test results, updating the history with latest flow test results and carrying out an analysis of the history of flow test results for each of the one or more supply channels of the reprocessing device (Nguyen paragraph 0043], “a plurality of fluid flow rate values can be stored in a look-up table defined within programmable memory on the PCB assembly 179…the values can be empirically tested and then stored in the programmable memory. In either event, the fluid flow rate can be determined as a function of the gauge pressure of the fluid being discharged by the circulation pump 162 and supplied to the manifold 166. In at least one such embodiment, a gauge pressure sensor, such as gauge pressure sensor 159 (FIG. 3), for example, can be positioned downstream with respect to the outlet of the circulation pump 162 such that the gauge pressure of the fluid being supplied to each of the reprocessor channel supply lines 164 can be measured. ”); and
indicating a problem with one of a supply channel of the one or more supply channels or a valve associated with the supply channel if the history of flow test results contains one or more flow test result anomalies in the supply channel that meet at least one or more predefined criteria (Nguyen paragraph [0046], “In the event that the actual flow rate of the fluid through the reprocessor supply line 164 is below the minimum acceptable value or above the maximum acceptable value stored in the look-up table for a given gauge pressure for a given reprocessor supply line 164, the PCB assembly 179 may open, partially open, close, and/or partially close the proportional valve 174 associated therewith.”).
Examiner interprets carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device, as disclosed by Nguyen presented above. However, if this interpretation, which is made in light of paragraph [0016] of the present specification (“Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device.”), is determined to be inaccurate, and this phrase is interpreted as the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device, Examiner cites Bruce as teaching the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device (Bruce paragraph [0541], “method 5000 returns to step 5016 where processor 1020 continues monitoring and recording sterilization process operating parameters during the sterilization process cycle”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Bruce’s explicit continuous monitoring of an endoscope reprocessing device with the method disclosed by Nguyen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope cleaning method that ensures sterilization of an endoscope.
With regard to Claim 2, Nguyen in view of Bruce teaches the features of Claim 1, as described above.
Nguyen further discloses wherein the one or more flow test result anomalies is a blockage of an endoscope channel (Nguyen paragraph [0040], “channels defined within the endoscope can be become blocked or obstructed by debris, for example, which can inhibit the endoscope from being properly cleaned, disinfected, and/or sterilized. In some circumstances, the debris positioned within an endoscope channel can at least partially block the flow of the fluid therethrough thereby reducing the rate in which the fluid can flow through the channel.” Examiner interprets this as disclosing a reason/fault responsible for creating a reduced flow, as described within Nguyen”) connected with the supply channel or a problem with the attachment of an endoscope channel to the supply channel.
With regard to Claim 8, Nguyen in view of Bruce teaches the features of Claim 1, as described above.
Nguyen further discloses wherein the flow tests of endoscope channels connected with the one or more supply channels are performed sequentially one after another or in several or all of the one or more supply channels in parallel at least one of before, during and after reprocessing of an endoscope (Nguyen paragraph [0069], “the devices and methods described herein can be designed to provide an adequate supply of reprocessing fluid to clean, disinfect, and/or sterilize an endoscope”. Examiner interprets the flow tests described above Nguyen paragraph [0038] as being the same process as the reprocessing of the endoscope.).
With regard to Claim 10, Nguyen discloses:
An endoscope reprocessing device (Nguyen FIG. 1, endoscope reprocessor 100) comprising:
a washing cabinet (Nguyen FIG. 1, reprocessor frame 140) configured to receive one or more endoscopes (Nguyen FIG. 17, endoscope 101) to be reprocessed;
a controller (Nguyen FIG. 9, PCB assembly 179; Nguyen paragraph [0047], “the microprocessor of the PCB assembly 179 can be configured to adjust the position of the valve element within the valve chamber 180 of the proportional valve 174”);
at least one source for a fluid (Nguyen FIG. 3, fluid pump 162 and manifold 166 within channel flow subsystem 160) controlled by the controller; and
one or more supply channels (Nguyen FIG. 3, supply lines 164) connecting the at least one source for fluid to the washing cabinet (Nguyen paragraph [0041], “endoscope reprocessor can comprise a channel flow subsystem 160 including a manifold 166 in fluid communication with the circulation system pump, indicated as pump 162, which can be configured to distribute the pressurized fluid to the channel supply lines of the endoscope reprocessor and then to the channels of the endoscope”, each of the one or more supply channels having an electronically controlled valve (Nguyen FIG. 3, valves 174) for opening and closing a respective supply channel and each of the one or more supply channels having a pressure sensor (Nguyen FIG. 3 pressure sensors 176) connected to the respective supply channel downstream of the valve;
wherein the controller is configured to:
carry out a running self-check of the reprocessing device at every endoscope reprocessing operation, the running self-check comprising keeping a history of flow test results, updating the history with latest flow test results and carrying out an analysis of the history of flow test results for each of the one or more supply channels (Nguyen paragraph 0043], “a plurality of fluid flow rate values can be stored in a look-up table defined within programmable memory on the PCB assembly 179…the values can be empirically tested and then stored in the programmable memory. In either event, the fluid flow rate can be determined as a function of the gauge pressure of the fluid being discharged by the circulation pump 162 and supplied to the manifold 166. In at least one such embodiment, a gauge pressure sensor, such as gauge pressure sensor 159 (FIG. 3), for example, can be positioned downstream with respect to the outlet of the circulation pump 162 such that the gauge pressure of the fluid being supplied to each of the reprocessor channel supply lines 164 can be measured. ”), and
indicating a problem with a supply channel of the one or more supply channels or a valve associated with the supply channel if the history of flow test results contains one or more flow test result anomalies in the supply channel that meet at least one or more predefined criteria (Nguyen paragraph [0046], “In the event that the actual flow rate of the fluid through the reprocessor supply line 164 is below the minimum acceptable value or above the maximum acceptable value stored in the look-up table for a given gauge pressure for a given reprocessor supply line 164, the PCB assembly 179 may open, partially open, close, and/or partially close the proportional valve 174 associated therewith.”).
Examiner interprets carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device, as disclosed by Nguyen presented above. However, if this interpretation, which is made in light of paragraph [0016] of the present specification (“Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device.”), is determined to be inaccurate, and this phrase is interpreted as the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device, Examiner cites Bruce as teaching the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device (Bruce paragraph [0541], “method 5000 returns to step 5016 where processor 1020 continues monitoring and recording sterilization process operating parameters during the sterilization process cycle”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Bruce’s explicit continuous monitoring of an endoscope reprocessing device with the method disclosed by Nguyen. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope cleaning method that ensures sterilization of an endoscope.
With regard to Claim 11, Nguyen in view of Bruce teaches the features of Claim 10, as described above.
Nguyen further discloses wherein the at least one source for fluid is connected via a switchable valve (Nguyen FIG. 3, valve 167) to a common bus channel (Nguyen manifold 166) from which the one or more supply channels branch off.
With regard to Claim 12, Nguyen in view of Bruce teaches the features of Claim 11, as described above.
Nguyen further discloses wherein the at least one source for fluid comprises a reprocessing fluid supply (Nguyen FIG. 3, water pump 162) and pressurized air supply (Nguyen FIG. 3, pressurized air source 190), the switchable valve has two positions for alternatively letting through the reprocessing fluid and the pressurized air (Nguyen paragraph [0051], “he endoscope reprocessor 100 can comprise one or more valves, such as valve 167, for example, which can be operated to permit a flow of pressurized air from a pressurized air source 190, for example, into the manifold 166. In at least one such embodiment, the pressurized air can force any remaining water, detergent, and/or sterilant out of the endoscope channels.”).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”) and Nishiyama et al. (US PGPUB 2021/0298871 – “Nishiyama”).
Regarding Claim 3, Nguyen in view of Bruce teaches the features of Claim 1, as described in the rejection of Claim 1 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose wherein the one or more predefined criteria is met for the supply channel when the one or more flow test result anomalies identified during flow testing of endoscope channels connected with the supply channel have occurred at least a first predefined number Ni of times within a second predefined number N2 of the most recent flow tests, with N2 being greater than Ni.
Nishiyama teaches wherein the one or more predefined criteria is met for the supply channel when the one or more flow test result anomalies identified during flow testing of endoscope channels connected with the supply channel have occurred at least a first predefined number Ni of times within a second predefined number N2 of the most recent flow tests, with N2 being greater than Ni (Nishiyama FIG. 2, statistical processing unit 102 within server 100; Nishiyama paragraph [0081], “statistical processing unit 102 generates a statistical value regarding a frequency at which it is determined that the preliminary cleaning has not been properly performed on the endoscope based on the preliminary cleaning history stored in the memory unit 104…the statistical value represents a preliminary cleaning failure rate”. Examiner interprets the cleaning failure rate as a historical rate of anomalies caused by failure to properly reprocess/clean the endoscope.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Nishiyama’s statistical analysis of past reprocessing/cleaning failures with the method taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that determines a trustworthiness of the endoscope reprocessing/cleaning process in order to assist the endoscope user to decide whether or not to accept/use an endoscope that has been reprocessed by a certain method.
Regarding Claim 4, Nguyen in view of Bruce and Nishiyama teach the features of Claim 3, as described above.
Nishiyama further teaches wherein the one or more predefined criteria is met for the supply channel when flow test result anomalies identified during flow testing of endoscope channels connected with the supply channel have occurred a third predefined number of times N3 in succession (Nishiyama FIG. 2, statistical processing unit 102 within server 100; Nishiyama paragraph [0081], “statistical processing unit 102 generates a statistical value regarding a frequency at which it is determined that the preliminary cleaning has not been properly performed on the endoscope based on the preliminary cleaning history stored in the memory unit 104…the statistical value represents a preliminary cleaning failure rate”. Examiner interprets the cleaning failure rate taught by Nishiyama as encompassing any and all past historical periods.).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”), Nishiyama et al. (US PGPUB 2021/0298871 – “Nishiyama”), and Dasdan et al. (US PGPUB 2015/0161678 – “Dasdan”).
Regarding Claim 5, Nguyen in view of Bruce and Nishiyama teach the features of Claim 4, as described in the rejection of Claim 4 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce and Nishiyama do not explicitly teach resetting a counter counting the number of times in which the one or more flow test result anomalies have been identified in successive flow tests of endoscope channels connected with the supply channel when a new flow test of an endoscope channel connected with the supply channel does not turn up a flow test result anomaly.
Dasdan teaches resetting a counter counting the number of times in which the one or more flow test result anomalies have been identified in successive flow tests of endoscope channels connected with the supply channel when a new flow test of an endoscope channel connected with the supply channel does not turn up a flow test result anomaly (Dasdan FIG. 5, block 504; Dasdan paragraph [0060], “one or more counters are reset in operation 504. Counters may be reset for any suitable purpose, such as resetting periodically to reduce the likelihood that recent variations in resource usage or failure rate is hidden by aggregation of a high number of executions over a long period of time. For instance, a reset may occur after an optimization trigger”. Examiner interprets a passed flow test, as taught by Nguyen in view of Nishiyama, as being a type of optimization.)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Dasdan’s counter reset with the method taught by Nguyen in view of Bruce and Nishiyama. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that allows an endoscope reprocessor to have a “clean slate” of error counts after the endoscope passes a flow test, in order to highlight only repetitious failures.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”) and Han et al. (US PGPUB 2022/0216688 – “Han”).
Regarding Claim 6, Nguyen in view of Bruce teaches the features of Claim 1, as described in the rejection of Claim 1 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose resetting counters for the number of identifications of the one or more test flow anomalies after a dedicated self-check of the reprocessing device.
Han teaches resetting counters after a self-check if performed (Han FIG. 1, 1s counter; Han paragraph [0014], “1 s counter is used for performing a first self-check 1 second after being first powered-on…after the first self-check is completed, the 1 s counter is turned off until the power-on reset signal is generated again, and then the 1 s counter is turned on again.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Han’s counter reset with the method taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a method that resets fault counters once a self-check is performed, in order to provide a “clean slate” of error counts after the system passes a self-check process.
With regard to Claim 7, Nguyen in view of Bruce and Han teaches the features of Claim 6, as described above.
Nguyen further discloses wherein dedicated self-check comprises using a test plate connected to the one or more supply channels (Nguyen FIG. 2, ports 114 connected to supply lines; see Nguyen paragraph [0039]. See also Nguyen FIG. 5, with outlets 163 on manifold 166 for endoscope reprocessing supply lines 164. Examiner notes that “test plate” is never defined or depicted in the specification/figures, and thus interprets “test plate” as any fluid passage/orifice/connection.).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”) and Malkin et al. (US PGPUB 2004/0091389 – “Malkin”).
Regarding Claim 9, Nguyen in view of Bruce teaches the features of Claim 1, as described in the rejection of Claim 1 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose generating and displaying or transmitting a message reporting a finding to a user or to a service provider in the event that a problem with the supply channel or valve associated with the supply channel is identified.
Malkin teaches generating and displaying or transmitting a message reporting a finding to a user or to a service provider in the event that a problem with the supply channel or valve associated with the supply channel is identified (Malkin FIG. 1, visual display 152 on reprocessing system 10; Malkin paragraph [0080], “Operation of the reprocessing system 10 can be monitored by sensors…which provide information to the central processor…Visual displays…error messages, status notifications and the like can be introduced to the user at the user interface 152.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the use of Malkin’s display with the method taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of a reprocessing/cleaning process of an endoscope having results that can be trusted and are error free.
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nguyen et al. (US PGPUB 2013/0098400 – “Nguyen”) in view of Bruce et al. (US PGPUB 2015/0374868 – “Bruce”) and Yang (US PGPUB 2019/0076009 – “Yang”).
Regarding Claim 13, Nguyen in view of Bruce teaches the features of Claim 12, as described in the rejection of Claim 12 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose wherein the switchable valve has a third position for closing off both the reprocessing fluid and the pressurized air.
Yang teaches wherein the switchable valve (Yang FIG. 15, 3-way valves 10161-1016n) has a third position for closing off both the reprocessing fluid (Yang FIG. 15, fluid from liquid pump 1004) and the pressurized air (Yang FIG. 15, air from air reservoir 1014).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yang’s 3-way valve with the device taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope reprocessor capable of selectively flushing air, liquid, or neither to the endoscope channel being cleaned.
Regarding Claim 14, Nguyen in view of Bruce teaches the features of Claim 11, as described in the rejection of Claim 11 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose wherein the at least one source for fluid comprises a reprocessing fluid supply and pressurized air supply and the reprocessing fluid supply and the pressurized air supply are connected directly to the one or more supply channels, wherein the switchable valve has three positions, a first position for letting through the processing fluid, a second position for letting through the pressurized air and a third position for closing off the supply channel.
Yang teaches:
wherein the at least one source for fluid comprises a reprocessing fluid supply (Yang FIG. 15, liquid pump 1004) and pressurized air supply (Yang FIG. 15, air reservoir 1014) and the reprocessing fluid supply and the pressurized air supply are connected directly to the one or more supply channels (Yang FIG. 15, channels 10321-1032n), wherein the switchable valve (Yang FIG. 15, 3-way valves 1016a-1016n respectively comprising a liquid inlet 1018a-1018n, an air inlet 1020a-1020n, and an outlet 1022a-1022n) has three positions, a first position for letting through the processing fluid, a second position for letting through the pressurized air and a third position for closing off the supply channel (Yang paragraph [0159], “One or more actuators (not shown) may be coupled with the moving components of each valve unit (1016a-1016n) to selectively transition the liquid inlet (1018a-1018n), air inlet (1020a-1020n), and/or outlet (1022a-1022n) of each valve unit (1016a-1016n) between respective open and closed state.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yang’s 3-way valve with the device taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope reprocessor capable of selectively flushing air, liquid, or neither to the endoscope channel being cleaned.
Regarding Claim 15, Nguyen in view of Bruce teaches the features of Claim 10, as described in the rejection of Claim 10 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly disclose a flow control unit in communication with the controller, the flow control unit having a flow controller being configured to control an operation of the electronically controlled valves of the one or more supply channels.
Yang teaches a flow control unit (Yang FIG. 15, valves 1016a-1016n) in communication with the main controller (Yang FIG. 15, controller 1024), the flow control unit having a flow controller being configured to control an operation of the electronically controlled valves of the one or more supply channels (Yang paragraph [0159], “Controller (1024) may be configured to drive the valve actuators to selectively control each valve unit (1016a-1016n) independently to deliver liquid and pressurized air to the respective internal channel (1032a-1032n) of medical device (1030) for selected durations of time.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yang’s 3-way valve with the device taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope reprocessor capable of selectively flushing air, liquid, or neither to the endoscope channel being cleaned.
Regarding Claim 16, Nguyen in view of Bruce teaches the features of Claim 10, as described in the rejection of Claim 10 under 35 U.S.C. 103 presented above.
Nguyen in view of Bruce does not explicitly teach wherein the controller is one of a main controller configured to control the reprocessing of endoscopes, a flow controller being configured to control an operation of the electronically controlled valves of the one or more supply channels or a computer system connected via a datalink to the endoscope reprocessing device.
Yang teaches wherein the controller is one of a main controller (Yang FIG. 15, controller 1024) configured to control the reprocessing of endoscopes, a flow controller being configured to control an operation of the electronically controlled valves of the one or more supply channels (Yang paragraph [0159], “Controller (1024) may be configured to drive the valve actuators to selectively control each valve unit (1016a-1016n) independently to deliver liquid and pressurized air to the respective internal channel (1032a-1032n) of medical device (1030) for selected durations of time.”) or a computer system connected via a datalink to the endoscope reprocessing device.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to combine Yang’s 3-way valve with the device taught by Nguyen in view of Bruce. A person having ordinary skill in the art would be motivated to combine these prior art elements according to known methods to yield the predictable result of an endoscope reprocessor capable of selectively flushing air, liquid, or neither to the endoscope channel being cleaned.
Response to Arguments
Applicant’s arguments, see page 9, filed on December 1, 2025, with respect to the objection to the figures have been fully considered and are persuasive, in view of the amendment to FIG. 1. The objection to the figures has been withdrawn.
Applicant’s arguments, see page 9, filed on December 1, 2025, with respect to the August 29, 2025 rejection of Claims 10, 15, and 16 under 35 U.S.C. 112(b) have been fully considered and are persuasive, in view of the amendments to the claims. The August 29, 2025 rejections of Claims 10, 15, and 16 have been withdrawn. However, as described above, Claim 10 is currently rejected under 35 U.S.C. 112(b) based on the present amendment thereof.
Applicant's arguments filed December 1, 2025 regarding the rejection of Claims 1-2, 8, 10-12 under 35 U.S.C. 102(a)(1), and more specifically based on the newly-added features in independent Claims 1 and 10 of carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation have been fully considered but they are not persuasive. As stated above, Examiner interprets carrying out a running self-check of the reprocessing device at every endoscope reprocessing operation as meaning that the self-check of the reprocessing device is monitored when an endoscope is introduced to the endoscope reprocessing device, as disclosed by Nguyen presented above. This interpretation is made in light of paragraph [0016] of the present specification, “Since the method can identify problems of the reprocessing device, it can provide a self-check functionality for the reprocessing device.”). In the alternative, if this phrase is interpreted as the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device, Examiner now also rejects Claims 1 and 10 under 35 U.S.C. 103, citing Bruce as teaching the self-check of the reprocessing device is continuously monitored when an endoscope is introduced to the endoscope reprocessing device (Bruce paragraph [0541], “method 5000 returns to step 5016 where processor 1020 continues monitoring and recording sterilization process operating parameters during the sterilization process cycle”).
Applicant's arguments filed December 1, 2025 regarding the rejection of Claims 3-7, 9, and 13-16 under 35 U.S.C. 103 for depending on Claims 1-2, 8, 10-12 are moot, based on the current rejection of Claims 1-2, 8, 10-12 under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 103.
Conclusion
THIS ACTION IS MADE FINAL. 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 JIM BOICE whose telephone number is (571)272-6565. The examiner can normally be reached Monday-Friday 9:00am - 5:00pm Eastern.
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, Anhtuan Nguyen can be reached at (571)272-4963. 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.
JIM BOICE
Examiner
Art Unit 3795
/JAMES EDWARD BOICE/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
1/24/26