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 .
Status of Claims
Claims 1-21 are pending, claims 5-6 and 17-21 have been withdrawn from consideration, and claims 1-4 and 7-16 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objections and 35 USC 112b Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4 and 7-16 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.
Claim Objections
Claims 1-2 and 7-8 are objected to because of the following informalities:
In claim 1, on the last line, change “data” to “data.” (i.e., missing a period).
In claim 2, on line 17, change “an operation” to “the operation”.
In claim 7, on line 12, change “identifying” to “identify”.
In claim 8, on line 17, change “an operation” to “the operation”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-4 and 7-16 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton (US 2020/0187768), in view of Woolford (US 2013/0267779) and Spargo (US 2024/0260823).
Regarding claim 1, Shelton discloses an endoscope fluid control system (see figure 3b), comprising: an endoscope (310b, figure 3b) including a first water suction or supply conduit (suction channel [0092]); a second water suction or supply conduit (256 and 326, figure 3a or 326, figure 3b) detachably connected (port 313, figure 3a or 313a, figure 3b | coupled to a…[0095]) to the first water suction or supply conduit; a pump (suction/irrigation control unit 340…a pump…[0094]; figure 3b) connected to the second water suction or supply conduit; a pressure gauge (working channel…differential pressure sensors…over a range of locations [0071] | one of the pressure sensor may be in the second water suction conduit for a range of locations) installed on the second water suction or supply conduit (working channel…for suction [0092]). Shelton is silent regarding a memory configured to record correlation data which indicates a correlation between a pressure value indicated by the pressure gauge and an output value of the pump and which is set for each type of endoscope, where the type of endoscope is defined based on a model or a production lot; and a processor, wherein the processor is configured to: identify correlation data corresponding to the type of the endoscope in which the first water suction or supply conduit is connected to the second water suction or supply conduit from the memory; monitor an operation of the pump based on the specified correlation data; and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump during operation falls within a normal range defined by the identified correlation data.
Woolford teaches a pump (14, figure 1a | 1014, figure 25b) with inflow and outflow cassettes (20 and 26, figure 1a | 1020 and 1026, figure 25b). The pump can have a pump memory device (1051, figure 25b) that stores information received by the pump control processor (1042, figure 25b) and can prestore information regarding various devices, the surgical devices, and various cutting accessories ([0137]). Identification information for each component is input into the pump control processor (1042, figure 25b), where the inflow and outflow tubing, along with other properties, is typically automatically read by RF communication or identified by the pump control processor when the inflow and outflow cassettes are inserted into the pump ([0141]). The pump control processor utilizes stored or read dimensions and other values for the known identified components to calculate a pressure loss (p.sub.loss) curve, with the details stored in the pump memory (1051, figure 25b | [0142]). An algorithm or program executed by the pump control processor calculates coefficients defining the p.sub.loss curve from the properties including the dimensions and length of the tubing (1022 [0142]). The p.sub.loss curve, coefficients and other information are stored in the pump memory of the pump control processor for future use with an identifier name, where they can be obtained in the future from a look-up table in the pump memory ([0242]). A check run routine is used to confirm the pump system is properly connected to the surgical site, that adequate fluid flow is being provided to the surgical site, and that the hardware secured to the pump is properly identified ([0167]).
Spargo teaches an endoscope (100, figure 1) with identification, evaluation, and closed-loop reprocessing of lumen(s) in the endoscope ([0083]). A method to identify the endoscope is by measuring fluidic parameters, such as pressure, flow rate, and computing a flow coefficient ([0083]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system with a pump control processor (1042, figure 25b) and a pump memory (1051, figure 25b) as taught by Woolford. Doing so would ease a hardware calibration routine by obtaining information from a look-up table in the pump memory ([0242]). Further, it would have been obvious to modify the system to use fluidic parameters to identify the endoscope ([0083]) as taught by Spargo. Doing so would provide a way to identify the medical device ([0083]). The modified system would have a memory (1051, figure 25b; Woolford) configured to record correlation data (details…stored in pump memory [0142]) which indicates a correlation between a pressure value indicated by the pressure gauge (pressure loss…[0142]) and an output value of the pump (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton) and which is set for each type of endoscope ([0137]; [0141]; Woolford), where the type of endoscope is defined based on a model or a production lot (pressure information regarding various devices…[0137]); and a processor (1042, figure 25b; Woolford), wherein the processor is configured to: identify correlation data corresponding to the type of the endoscope in which the first water suction or supply conduit is connected to the second water suction or supply conduit from the memory (details for the…stored in pump memory [0142]; Woolford | identify the endoscope by measuring fluidic parameters [0083]; Spargo); monitor an operation of the pump based on the specified correlation data (input to the pump control processor…pump memory [0242] | controlling the pump to provide…[0180]; Woolford); and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump (measuring fluid parameters [0083]; Spargo) during operation falls within a normal range defined by the identified correlation data (compared with the stored normalized slope…alert [0165]; Woolford).
Regarding claim 2, Shelton and Woolford and Spargo further disclose the memory (1051, figure 25b; Woolford) is configured to record (details….stored in pump memory [0142]), at least for each type of endoscope (obtain information…surgical device…[0137]), first minimum correlation data that is constructed based on a first pressure value (pressure loss…[0142]) indicated by the pressure gauge and an output value of the pump corresponding to the first pressure value (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton), and the processor is configured to: construct second minimum correlation data based on a second pressure value (p.sub.loss curve [0142]; Woolford | p.sub.loss value…curve for an RPM value…[0143] | interpreted there to be a second pressure value) measured by the pressure gauge and the output value of the pump corresponding to the second pressure value (RPM value…[0143] | interpreted there to be an associated RPM value of the pump) when the first water suction conduit is connected to the second water suction conduit and the pump is operated; identify correlation data which approximates combined data of the first minimum correlation data and the second minimum correlation data from among the correlation data which is set for each type of endoscope and is recorded in the memory (identifying….obtained from a look-up table…memory [0242]; Woolford | identifying…measuring fluid parameters [0083]; Spargo); and monitor an operation of the pump based on the identified correlation data (input to the pump control processor…pump memory [0242] | controlling the pump to provide…[0180] | compared with the stored normalized slope…alert [0165]; Woolford).
Regarding claim 3, Shelton further discloses the endoscope includes an internal pressure sensor (working channel…differential pressure sensors…over a range of locations [0071]; Shelton) in a distal end portion of an insertion portion (see distal end of 311, figure 3b), and the processor is configured to: calculate a difference between a first relative change amount of a pressure value measured by the pressure gauge from a first reference value (flow sensor…differential pressure sensors [0071] | decrease in the sensed flow rate…[0072] | interpreted the reference value to be the pressure value before the decrease) and a second relative change amount of a pressure value measured by the internal pressure sensor from a second reference value (differential pressure sensors [0071]; interpreted there to be a second pressure sensor | decrease in the sensed flow rate…[0072] | interpreted the reference value to be the pressure value before the decrease for the second pressure sensor); and determine that the internal pressure sensor is abnormal when the difference exceeds a threshold (below a first flow rate threshold [0072]).
Regarding claim 4, Shelton further discloses the pressure gauge is installed on the second water suction conduit between the pump and the first water suction conduit (working channel…differential pressure sensors…over a range of locations [0071]; Shelton | one of the pressure sensor may be in the second water suction conduit for “range of locations”).
Regarding claim 7, Shelton discloses a fluid control apparatus (see figure 3b) for an endoscope (310b, figure 3b), comprising: a second water suction or supply conduit (356 and 326, figure 3a or 326, figure 3b) detachably connected (port 313, figure 3a or 313a, figure 3b | coupled to a…[0095]) to a first water suction or supply conduit (suction channel [0092]) included in an endoscope (310b, figure 3b); a pump (suction/irrigation control unit 340…a pump…[0094]; figure 3b) connected to the second water suction or supply conduit; a pressure gauge (working channel…differential pressure sensors…over a range of locations [0071] | one of the pressure sensor may be in the second water suction conduit for a “range of locations”) installed on the second water suction or supply conduit (working channel…for suction [0092]). Shelton is silent regarding a memory configured to record correlation data which indicates a correlation between a pressure value indicated by the pressure gauge and an output value of the pump and which is set for each type of [[the]] endoscope, where the type of endoscope is defined based on a model or a production lot; and a processor, wherein the processor is configured to: identifying correlation data corresponding to a type of the endoscope in which the first water suction or supply conduit of which is connected to the second water suction or supply conduit;[[and]] monitor an operation of the pump based on the identified correlation data: and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump during operation falls within a normal range defined by the identified correlation data.
Woolford teaches a pump (14, figure 1a | 1014, figure 25b) with inflow and outflow cassettes (20 and 26, figure 1a | 1020 and 1026, figure 25b). The pump can have a pump memory device (1051, figure 25b) that stores information received by the pump control processor (1042, figure 25b) and can prestore information regarding various devices, the surgical devices, and various cutting accessories ([0137]). Identification information for each component is input into the pump control processor (1042, figure 25b), where the inflow and outflow tubing, along with other properties, is typically automatically read by RF communication or identified by the pump control processor when the inflow and outflow cassettes are inserted into the pump ([0141]). The pump control processor utilizes stored or read dimensions and other values for the known identified components to calculate a pressure loss (p.sub.loss) curve, with the details stored in the pump memory (1051, figure 25b | [0142]). An algorithm or program executed by the pump control processor calculates coefficients defining the p.sub.loss curve from the properties including the dimensions and length of the tubing (1022 [0142]). The p.sub.loss curve, coefficients and other information are stored in the pump memory of the pump control processor for future use with an identifier name, where they can be obtained in the future from a look-up table in the pump memory ([0242]). A check run routine is used to confirm the pump system is properly connected to the surgical site, that adequate fluid flow is being provided to the surgical site, and that the hardware secured to the pump is properly identified ([0167]).
Spargo teaches an endoscope (100, figure 1) with identification, evaluation, and closed-loop reprocessing of lumen(s) in the endoscope ([0083]). A method to identify the endoscope is by measuring fluidic parameters, such as pressure, flow rate, and computing a flow coefficient ([0083]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the apparatus with a pump control processor (1042, figure 25b) and a pump memory (1051, figure 25b) as taught by Woolford. Doing so would ease a hardware calibration routine by obtaining information from a look-up table in the pump memory ([0242]). Further, it would have been obvious to modify the apparatus to use fluidic parameters to identify the endoscope ([0083]) as taught by Spargo. Doing so would provide a way to identify the medical device ([0083]). The modified apparatus would have a memory (1051, figure 25b; Woolford) configured to record correlation data (details…stored in pump memory [0142]) which indicates a correlation between a pressure value indicated by the pressure gauge (pressure loss…[0142]) and an output value of the pump (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton) and which is set for each type of [[the]] endoscope ([0137]; [0141]; Woolford), where the type of endoscope is defined based on a model or a production lot (pressure information regarding various devices…[0137]; Woolford); and a processor (1042, figure 25b; Woolford), wherein the processor is configured to: identifying correlation data corresponding to a type of the endoscope in which the first water suction or supply conduit of which is connected to the second water suction or supply conduit (details for the…stored in pump memory [0142]; Woolford | identify the endoscope by measuring fluidic parameters [0083]; Spargo); monitor an operation of the pump based on the identified correlation data (input to the pump control processor…pump memory [0242] | controlling the pump to provide…[0180]; Woolford); and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump (measuring fluid parameters [0083]; Spargo) during operation falls within a normal range defined by the identified correlation data (compared with the stored normalized slope…alert [0165]; Woolford).
Regarding claim 8, Shelton and Woolford and Spargo further disclose the memory (1051, figure 25b; Woolford) is configured to record (details….stored in pump memory [0142]; Woolford), at least for each type of endoscope (obtain information…surgical device…[0137]), first minimum correlation data that is constructed based on a first pressure value (pressure loss…[0142]) indicated by the pressure gauge and an output value of the pump corresponding to the first pressure value (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton), and the processor is configured to: construct second minimum correlation data based on a second pressure value (p.sub.loss curve [0142]; Woolford | p.sub.loss value…curve for an RPM value…[0143] | interpreted there to be a second pressure value) measured by the pressure gauge and the output value of the pump corresponding to the second pressure value (RPM value…[0143] | interpreted there to be an associated RPM value of the pump) when the first water suction conduit is connected to the second water suction conduit and the pump is operated; identify correlation data which approximates combined data of the first minimum correlation data and the second minimum correlation data from among the correlation data which is set for each type of endoscope and is recorded in the memory (identifying….obtained from a look-up table…memory [0242]; Woolford | identifying…measuring fluid parameters [0083]; Spargo); and monitor an operation of the pump based on the identified correlation data (input to the pump control processor…pump memory [0242] | controlling the pump to provide…[0180] | compared with the stored normalized slope…alert [0165]; Woolford).
Regarding claim 9, Woolford and Spargo further teach the processor is configured to select, based on information transmitted from an operating switch (user interface 341, figure 3b; Shelton | see buttons/switches in figure 3b) in accordance with an operation by a user, one type of correlation data from among correlation data set for each type of endoscope which is recorded in the memory (identifying….obtained from a look-up table…memory [0242]; input device for inputting information directly…[0137]; Woolford | identifying…measuring fluid parameters [0083]; Spargo).
Regarding claim 10, Woolford and Spargo further teach the processor is configured to select, in accordance with a type of the endoscope the first water suction conduit of which is connected to the second water suction conduit, one type of correlation data from among correlation data set for each type of the endoscope which is recorded in the memory (identifying….obtained from a look-up table…memory [0242]; Woolford | identifying…measuring fluid parameters [0083]; Spargo).
Regarding claim 11, Shelton further discloses the pressure gauge is installed on the second water suction conduit between the pump and the first water suction conduit (working channel…differential pressure sensors…over a range of locations [0071]; Shelton | one of the pressure sensor may be in the second water suction conduit for “range of locations”).
Regarding claim 12, Shelton discloses a fluid control apparatus (see figure 3b) for an endoscope (310b, figure 3b), comprising: a second water or supply suction conduit (356 and 326, figure 3a or 326, figure 3b) detachably connected (port 313, figure 3a or 313a, figure 3b | coupled to a…[0095]) to a first water suction or supply conduit (suction channel [0092]) included in an endoscope (310b, figure 3b); a pump (suction/irrigation control unit 340…a pump…[0094]; figure 3b) connected to the second water suction or supply conduit; a pressure gauge (working channel…differential pressure sensors…over a range of locations [0071] | one of the pressure sensor may be in the second water suction conduit for a “range of locations”) installed on the second water suction or supply conduit. Shelton is silent regarding a memory configured to record first minimum correlation data which indicates a correlation between a pressure value indicated by the pressure gauge and an output value of the pump and which is constructed based on a first pressure value indicated by the pressure gauge and an output value of the pump corresponding to the first pressure value; and a processor, wherein the processor is configured to: construct second minimum correlation data based on a second pressure value measured by the pressure gauge and the output value of the pump corresponding to the second pressure value when the first water suction or supply conduit is connected to the second water suction or supply conduit and the pump is operated; construct correlation data based on a combination of the first minimum correlation data and the second minimum correlation data; monitor an operation of the pump based on the constructed correlation data; and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump during operation falls within a normal range defined by the constructed correlation data.
Woolford teaches a pump (14, figure 1a | 1014, figure 25b) with inflow and outflow cassettes (20 and 26, figure 1a | 1020 and 1026, figure 25b). The pump can have a pump memory device (1051, figure 25b) that stores information received by the pump control processor (1042, figure 25b) and can prestore information regarding various devices, the surgical devices, and various cutting accessories ([0137]). Identification information for each component is input into the pump control processor (1042, figure 25b), where the inflow and outflow tubing, along with other properties, is typically automatically read by RF communication or identified by the pump control processor when the inflow and outflow cassettes are inserted into the pump ([0141]). The pump control processor utilizes stored or read dimensions and other values for the known identified components to calculate a pressure loss (p.sub.loss) curve, with the details stored in the pump memory (1051, figure 25b | [0142]). An algorithm or program executed by the pump control processor calculates coefficients defining the p.sub.loss curve from the properties including the dimensions and length of the tubing (1022 [0142]). The p.sub.loss curve, coefficients and other information are stored in the pump memory of the pump control processor for future use with an identifier name, where they can be obtained in the future from a look-up table in the pump memory ([0242]). A check run routine is used to confirm the pump system is properly connected to the surgical site, that adequate fluid flow is being provided to the surgical site, and that the hardware secured to the pump is properly identified ([0167]).
Spargo teaches an endoscope (100, figure 1) with identification, evaluation, and closed-loop reprocessing of lumen(s) in the endoscope ([0083]). A method to identify the endoscope is by measuring fluidic parameters, such as pressure, flow rate, and computing a flow coefficient ([0083]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the apparatus with a pump control processor (1042, figure 25b) and a pump memory (1051, figure 25b) as taught by Woolford. Doing so would ease a hardware calibration routine by obtaining information from a look-up table in the pump memory ([0242]). Further, it would have been obvious to modify the apparatus to use fluidic parameters to identify the endoscope ([0083]) as taught by Spargo. Doing so would provide a way to identify the medical device ([0083]). The modified apparatus would have a memory (1051, figure 25b; Woolford) configured to record first minimum correlation data (details…stored in pump memory [0142]) which indicates a correlation between a pressure value indicated by the pressure gauge (pressure loss…[0142]) and an output value of the pump (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton) and which is constructed based on a first pressure value (pressure loss…[0142]; Woolford) indicated by the pressure gauge and an output value of the pump corresponding to the first pressure value (RPM…motor [0142]; Woolford | suction/irrigation control unit 340…a pump…[0094]; figure 3a of Shelton); and a processor (1042, figure 25b; Woolford), wherein the processor is configured to: construct second minimum correlation data based on a second pressure value (p.sub.loss curve [0142] | p.sub.loss value…curve for an RPM value…[0143] | interpreted there to be a second pressure value) measured by the pressure gauge and the output value of the pump corresponding to the second pressure value (RPM value…[0143] | interpreted there to be an associated RPM value of the pump) when the first water suction or supply conduit is connected to the second water suction or supply conduit and the pump is operated; construct correlation data based on a combination of the first minimum correlation data and the second minimum correlation data (identifying….obtained from a look-up table…memory [0242]; Woolford | identifying…measuring fluid parameters [0083]; Spargo); monitor an operation of the pump based on the constructed correlation data (input to the pump control processor…pump memory [0242] | controlling the pump to provide…[0180]; Woolford); and determine that a water suction system is operating normally when a pressure value indicated by the pressure gauge at an output value of the pump during operation falls within a normal range defined by the constructed correlation data (compared with the stored normalized slope…alert [0165]; Woolford).
Regarding claim 13, Woolford and Spargo further teach the memory is configured to record a plurality (pressure information regarding various devices…[0137]; Woolford) of first minimum correlation data (pressure loss…[0142]; RPM…motor [0142]; Woolford), each first minimum correlation data corresponding to a different first pressure value (pressure loss…[0142]) indicated by the pressure gauge or a different output value of the pump (RPM…motor [0142]; Woolford), and the processor is configured to select one type of first minimum correlation data from among the plurality of types of first minimum correlation data recorded in the memory (details for the…stored in pump memory [0142]; Woolford | identify the endoscope by measuring fluidic parameters [0083]; Spargo).
Regarding claim 14, Woolford and Spargo further teach the processor is configured to select, in accordance with the endoscope in which the first water suction conduit is connected to the second water suction conduit, one first minimum correlation data from among the plurality of first minimum correlation data recorded in the memory (details for the…stored in pump memory [0142]; Woolford | identify the endoscope by measuring fluidic parameters [0083]; Spargo).
Regarding claim 15, Shelton and Woolford and Spargo further disclose the processor is configured to select, based on information transmitted from an operating switch (user interface 341, figure 3b; Shelton | see buttons/switches in figure 3b) in accordance with an operation by a user, one first minimum correlation data from among the plurality of first minimum correlation data recorded in the memory (identifying….obtained from a look-up table…memory [0242]; input device for inputting information directly…[0137]; Woolford | identifying…measuring fluid parameters [0083]; Spargo).
Regarding claim 16, Woolford and Spargo further teach the processor is configured to: acquire type information from the endoscope the first water suction conduit of which is connected to the second water suction conduit; and determine the type of the endoscope based on the type information (identifying….obtained from a look-up table…memory [0242]; Woolford | identifying…measuring fluid parameters [0083]; Spargo).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Velazquez (US 2022/0400936) disclose system pressure is set based on the type and/or configuration of an endoscope ([0083]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
May 16, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
Prosecution Insights