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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-15 in the reply filed on 7-9-26 is acknowledged.
Claims 16-21 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9-18-24.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recite(s) “acquiring a change rate” and “determination step of determining whether the endoscope pipe line is in an open or blocked state based on the change rate acquired in the change rate acquisition step”, this could be a mental step. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitation of “determining” and “based on” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, “acquiring”, “determining” and “based on” in the context of this claim encompasses the user mentally calculating a change rate and judging if the endoscope pipe is clogged by the observation of the calculation.
This judicial exception is not integrated into a particular practical application because once the determination is made nothing is done with the determination. Therefore, the judicial exception is not integrated into any process, nor a particular practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites supplying a pressurized fluid into an endoscope pipeline, which is well understood, routine and conventional in the art of operating an endoscope. Claim 1 is therefore not patent eligible.
Claim 4 recite “a calculation step of calculating the change rate based on the physical quantity data detected in the detection step”, this could be a mental step including a mathematical calculation. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitation of “calculating” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind or with pen and paper. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, “calculating” in the context of this claim encompasses the user mentally or with pen and paper calculating a change rate with collected data.
This judicial exception is not integrated into a particular practical application because once the calculation is made a determination is made based on the calculations and nothing is done with the determination. Therefore, the judicial exception is not integrated into any process, nor a particular practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites supplying a pressurized fluid into an endoscope pipeline, which is well understood, routine and conventional in the art of operating an endoscope. Claim 4 is therefore not patent eligible.
Claim 12 recite “an outlier exclusion step of specifying an outlier included in the physical quantity data based on the physical quantity data”, this could be a mental step. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitation of “specifying an outlier” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, “specifying an outlier” in the context of this claim encompasses the user mentally deciding which data points of a collection data qualify as outliers.
This judicial exception is not integrated into a particular practical application because once the judgment is made the date is excluded from the calculations resulting in a determination being made and nothing is done with the determination. Therefore, the judicial exception is not integrated into any process, nor a particular practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites supplying a pressurized fluid into an endoscope pipeline, which is well understood, routine and conventional in the art of operating an endoscope. Claim 12 is therefore not patent eligible.
Claim 13 recite “determining a degree of a variation in the physical quantity data”, this could be a mental step. The courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer (MPEP 2106.04(a)(2) section Ill). The limitation of “determining” as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind. That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, “determining” in the context of this claim encompasses the user mentally judging a degree of variation of a collection data.
This judicial exception is not integrated into a particular practical application because once the judgment is made nothing is done with the judgment. Therefore, the judicial exception is not integrated into any process, nor a particular practical application.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The claim recites supplying a pressurized fluid into an endoscope pipeline, which is well understood, routine and conventional in the art of operating an endoscope. Claim 13 is therefore not patent eligible.
The remaining claims 2-3, 5-11 and 14-15 further modify the abstract ideas discussed above and/or recite well understood, routine and conventional features in the art of operating an endoscope and therefore are not patent eligible for the same reasons above.
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(s) 1-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Feld et al. US 2007/0100204 (US’204)(cited in IDS filed 12-11-24) in view of Yuma et al. JP 2016209461 (JP’461) (machine translation used for citation).
Regarding claim 1, US’204 teaches a state determination method for an endoscope pipe line (This invention relates to the field of reprocessors for devices, particularly medical devices, and more particularly to endoscopes and the like having one or more internal passageways which are to be cleaned and disinfected by an automatic reprocessor, the system will determine that a blockage exists in one or both of channels 77 and 77' or that channel 77 or channel 77' (or both) are disconnected, each of which conditions require that reprocessing be interrupted and the condition appropriately corrected, para. 1 and 35), comprising:
a supply step of supplying a pressurized fluid into an endoscope pipe line (FIG. 10 illustrates more detail about the first embodiment of the present invention in which the system 100 of FIG. 6 is used. Valve 114 is opened to air from cylinder 108 at a pressure of 20 psi at time t1, 120, para. 43-46, see fig. 10 and 6);
a change acquisition step of acquiring a change, which is a change amount of the fluid within a determination period after the supply of the fluid is stopped (the incremental time from t1 120 to t2 122 is measured, by monitoring the appropriate switch 98, set to trip at 2 psi, para. 43, see fig. 10);
and a determination step of determining whether the endoscope pipe line is in an open or blocked state based on the change acquired in the change acquisition step (The actual time (tactual=t2 -t1) is compared to the previously recorded characteristic time tCHAR to determine the connectivity condition of the channel under test, the solid line curve 124 illustrates the pressure decay for a connected and open (unblocked) channel, while dashed line 126 represents a disconnected channel, with switch 98 activating at time 127, If there is a decay, the channel is connected and open; if there is no decay, the channel is either disconnected or blocked, and must be corrected before continuing reprocessing the endoscope, para. 43-49, see fig. 10).
US’204 does not teach the change is a change rate of acquiring a change rate, which is a change amount per unit time of a physical quantity of the fluid and the determination is based on the change rate.
JP’461 teaches a pneumoperitoneum system capable of highly accurately determining an occluded state (abstract). JP’461 further teaches the pneumoperitoneum system: calculates a pressure gradient Ra of a measurement duct to determine an occluded state of the measurement duct and transfers to processing according to the determination result of the occluded state (abstract). The occlusion state determination unit 103 determines the normal state when the elapsed time measured by the change time measurement unit 102 is equal to or less than the first determination threshold Th1, and exceeds the first determination threshold Th1. When it is less than the second determination threshold Th2, it is determined that the state is slightly occluded (page 7). The manner in which this delay occurs varies depending on the degree of blockage of the measurement pipe 19. After the air supply is turned off from on, in the state where there is no blockage in the pipeline, there is almost no delay in the measured pressure Pm as shown by the line L1 in FIG. As the degree of blockage of the pipeline increases (page 6-7). Therefore, JP’461 teaches calculating the pressure gradient of the measurement of US’204, which reads on the change amount per unit time, can be used to not only determine the blocked state, but further determine the degree of blockage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of US’204 to include the change is a change rate of acquiring a change rate, which is a change amount per unit time of a physical quantity of the fluid and the determination is based on the change rate because JP’461 teaches it can be done to determine the degree of blockage in the method of US’204 and use of known technique to improve similar methods in the same way is obvious, see MPEP 2141 III (C).
Regarding claim 2, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 1. US’204 further teaches wherein the physical quantity is a pressure or a flow rate of the fluid (as discussed above, the physical quantity is a pressure of a fluid in a channel of the endoscope).
Regarding claim 3, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 1. US’204 further teaches wherein the supply of the fluid is stopped after the endoscope pipe line is filled with the fluid in the supply step (the channel is filled or charged with a fluid of gas to 20psi, para. 39-51).
Regarding claim 4, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 1. The modified method US’204 further teaches wherein the change rate acquisition step includes a detection step of detecting physical quantity data indicating a physical quantity of the fluid corresponding to each of a plurality of time points within the determination period, PCT(CA) and a calculation step of calculating the change rate based on the physical quantity data detected in the detection step (JP’461 further teaches the change time is measured as an elapsed time until the rate of change in the pipe pressure of the measurement pipe 19 reaches a set value, and the delay state of the pressure behavior due to the blockage of the pipe is determined by this elapsed time, page 5-7).
Regarding claim 5, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 4. The modified method US’204 further teaches wherein the calculation step includes conversion processing of converting the change rate into a constant (the calculation is performed to determine the gradient slope of the line of the time vs pressure measurement values, as discussed above).
Regarding claim 14, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 5. The modified method US’204 further teaches in the determination step, the determination is performed by comparing the change rate that is converted into the constant by the conversion processing with a determination threshold value indicating whether the endoscope pipe line is open or blocked (the gradient is compared to a threshold value, as discussed above)
Regarding claim 15, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 1. The modified method of US’204 further teaches wherein the determination period is a period after a preset exclusion period has elapsed from the stop of the supply of the fluid (JP’461 teaches a response delay of a predetermined time Td occurs after the control signal is sent to the electromagnetic valve 23 until the valve actually starts to close (usually, Td = 20 msec). During this response delay, as shown in FIG. 10, the pressure gradient Rb hardly changes, and after the delay time Td, the pressure gradient Rb gradually starts to change, page 8).
Claim(s) 6 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over US’204 in view of JP’461 as applied to claim 5 above, and further in view of Willeke US 4,846,166 (US’166).
Regarding claim 6, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 5.
The modified method of US’204 does not teach in the calculation step, as the conversion processing, logarithmic conversion is performed on at least one of the physical quantity data or time data indicating an elapsed time from a start of the determination period, to convert the change rate into the constant.
US’166 teaches a quantitative respirator fit testing (abstract). The process includes measuring a pressure drop over time inside a sealed medical device after the pressure source is turned off to check for leaks (col. 14-15). When the results of the experimental decay curve are plotted on a log-linear plot, with the pressure on the logarithmic scale and the time on the linear scale, a straight line results with the slope as an indicator of the rate of pressure decay. During exercising and/or during unsteady leakage, the pressure curve will show diverse results and the fit of the face mask or respirator is given by the slope of the curve on the linear-log plot before and after the unsteady leakage, when the facial contours are the same. Logarithmic amplification of the pressure signal will facilitate the numerical determination of the slope value (col. 15). When the results of the experimental decay curve are plotted on a log-linear plot, with the pressure on the logarithmic scale and the time on the linear scale, a straight line results with the slope as an indicator of the rate of pressure decay. During exercising and/or during unsteady leakage, the pressure curve will show diverse results and the fit of the face mask or respirator is given by the slope of the curve on the linear-log plot before and after the unsteady leakage, when the facial contours are the same. Logarithmic amplification of the pressure signal will facilitate the numerical determination of the slope value (col. 19). Therefore, US’166 teaches when performing pressure test on medical device channels to determine the state of the channel, i.e. leaks, performing a logarithmic conversion of the pressure signal will facilitate the numerical determination of the slope value.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of US’204 to include in the calculation step, as the conversion processing, logarithmic conversion is performed on at least one of the physical quantity data or time data indicating an elapsed time from a start of the determination period, to convert the change rate into the constant because US’166 teaches medical device leak test can include logarithmic conversion of the pressure signal facilitating the numerical determination of the slope value and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, see MPEP 2141 III (F).
Regarding claim 13, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 5.
The modified method of US’204 does not teach a variation determination step of determining a degree of a variation in the physical quantity data based on the physical quantity data after the conversion processing is performed.
US’166 teaches a quantitative respirator fit testing (abstract). The process includes measuring a pressure drop over time inside a sealed medical device after the pressure source is turned off to check for leaks (col. 14-15). The faster the pressure decreases, the larger the leak. A steady leak flow during breath holding without facial movement will result in a smooth decay curve during unsteady leakage, the pressure curve will show diverse results, and the fit of the face mask or respirator is given by the slope of the curve on the linear-log plot before and after the unsteady leakage, when the facial contours are the same. Logarithmic amplification of the pressure signal will facilitate the numerical determination of the slope value (col. 15) therefore US’166 teaches disruptions to leak checks can be compensated for by determining data variations that outlie expected values indicative of disruptions of the test.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of US’204 to include a variation determination step of determining a degree of a variation in the physical quantity data based on the physical quantity data after the conversion processing is performed because US’166 teaches disruptions to leak checks can be compensated for by determining data variations that outlie expected values indicative of disruptions of the test and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, see MPEP 2141 III (F).
Claim(s) 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over US’204 in view of JP’461 as applied to claim 5 above, and further in view of Wang et al. US 2010/0214110 (US’110).
Regarding claims 7-9, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 5.
The modified method of US’204 does not teach in the calculation step, the change rate is calculated based on time-division data obtained by time-dividing the physical quantity data for each time, with regard to claim 7, in the calculation step, the change rate is calculated by performing linearPCT(CA) approximation of the time-division data, with regard to claim 8 and in the calculation step, the change rate is calculated based on a slope between two points included in the time-division data, with regard to claim 9.
US’110 teaches a method of monitoring pressure inside a fluid line and a system for implementing the method. The method is applicable to syringe pump systems (abstract). One example of a medical pump system used to gradually deliver small amounts of fluid to patients is a syringe pump. More particularly, the present invention relates to a software algorithm that detects occlusions in the fluid lines of a syringe pump system (para. 3-6). Referring to FIG. 3, there is shown an example of a force-time-curve 50. The force-time curve 50 is a plot of the force reading 40 measured by loadcell sensor 30 over time. A best-fit line for the force-time curve 50 may be calculated by a linear regression equation for different segments of force-time curve 50. Based on the slope 62 of the best-fit line 64 for the force-time curve 50 in the first window 54 and the slope 66 of the best-fit line 65 for the force-time curve 50 in the second window 55, a slope difference 60 may then be calculated (para. 29). The size of the moving windows 54 and 55 must be selected. The accuracy of turning point 52 corresponds to the size of windows 54, 55. Accordingly, if the windows 54 and 55 are small, the possibility of false alarms may increase because turning point 54 will be subject to more noise and may be less accurate. Conversely, if the windows 54 and 55 are large, the turning point 52 will be more accurate, but the time required to establish the baseline 72 will increase. This can lead to an increased risk that the preset pressure triggering level 82 or force triggering level 76 will be reached before baseline 72 can be calculated. Since an alarm may not be triggered before the baseline 72 is established, the occlusion could go undetected. Thus, an optimal window size 87 produces the most accurate turning point 52, but the time taken to establish turning point 52 will be relatively long. A minimum window size 88 is the smallest window required in order to find the turning point 52 (para. 37). Therefore, US’110 teaches detecting an occlusion in a medical device fluid line by segmenting the time of a pressure test into time windows and calculating the slope of each time window to improve the reliability of the test by preventing false alarms and prevent occlusion from being undetected.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of US’204 to include in the calculation step, the change rate is calculated based on time-division data obtained by time-dividing the physical quantity data for each time, with regard to claim 7, in the calculation step, the change rate is calculated by performing linearPCT(CA) approximation of the time-division data, with regard to claim 8 and in the calculation step, the change rate is calculated based on a slope between two points included in the time-division data, with regard to claim 9 because US’110 teaches to improve the reliability of the test by preventing false alarms and prevent occlusion from being undetected and known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art, see MPEP 2141 III (F).
Regarding claim 10, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 7. The modified method of US’204 further teaches in the calculation step, the change rate is calculated by performing linear approximation based on a residual of the time-division data (US’110 teaches a best-fit line for the force-time curve 50 may be calculated by a linear regression equation for different segments of force-time curve 50. In one embodiment, the best-fit line is determined by a least squares method. As shown in FIG. 3, the force-time curve 50 has a turning point 52, para. 29, wherein a linear regression equation reads on performing linear approximation based on a residual).
Regarding claim 11, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 7. The modified method of US’204 further teaches in the calculation step, the change rate is calculated by performing linear approximation in which a sum of squares of residuals of the time-division data is minimized (US’110 teaches the best-fit line is determined by a least squares method, para. 29 and 38).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over US’204 in view of JP’461 as applied to claim 5 above, and further in view of Birnkrant et al. US 2023/0181019 (US’019).
Regarding claim 12, the modified method of US’204 teaches the state determination method for an endoscope pipe of claim 5.
The modified method of US’204 does not teach an outlier exclusion step of specifying an outlier included in the physical quantity data based on the physical quantity data after the conversion processing is performed, to exclude the outlier from the physical quantity data.
US’019 teaches an endoscopic system and method for its operation are disclosed (abstract). In order to illustrate typical operating conditions of the system described in FIGS. 9-10, attention is now drawn to FIG. 11A-D illustrating pressure data collected by the pressure sensor 76 over a 25 second run time for a variety of use cases for the system 10. The graphs show time in seconds on the X-axis, which, for illustrative purposes, includes a range from 0 seconds to 25 seconds. A number of discrete time ranges, indicated by Roman numerals, I-X, illustrate the detection of use events by the flush detection module 81. The graphs show pressure values P detected by the pressure sensor, and displayed as a percentage P (%) (solid line) of a maximum pressure PMAX PMAX may be the maximum pressure provided by the rinsing device 70, or another arbitrary, normalized value. FIGS. 11A.11B and 11D show raw data collected by the pressure sensor 76, while the data presented in FIG. 11C has been filtered to remove data spikes and noise and to smooth the overall curve (para. 73).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method of US’204 to include an outlier exclusion step of specifying an outlier included in the physical quantity data based on the physical quantity data after the conversion processing is performed, to exclude the outlier from the physical quantity data because US’019 teaches removing data spikes removes noise from the data and use of known technique to improve similar methods in the same way is obvious, see MPEP 2141 III (C).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN FLANAGAN BERGNER whose telephone number is (571)270-1133. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joshua Allen can be reached at 571-270-3176. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN F BERGNER/Primary Examiner, Art Unit 1713
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