DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/02/2026 has been entered.
Response to Amendment
The Amendment filed 02/02/2026 has been entered. Claims 1-12 and 16-20 remain pending and are being examined herein.
Status of Objections and Rejections
The rejections under 35 U.S.C 112(a) and 35 U.S.C 112(b) are being withdrawn in view of Applicant’s amendment.
New grounds for rejection under 35 U.S.C. 112(b) are necessitated by Applicant’s amendments.
The objections to the claims have been withdrawn in view of Applicant's amendment.
The rejections under 35 USC 103 are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments
Claim Objections
Claim 1 is objected to because of the following informalities:
p. 3, line 17, “after feeding the sterilizing agent” should read “after feeding the sterilizing agent into the first waste liquid tank”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-12 and 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “a sterilization dwell period” in the last two lines of the claim. In the original claim set of 01/25/2022, a “sterilization dwell period” is not recited and the term “sterilization dwell period” is not used in the specification. The specification discloses the “first prescribed time” in para. 0035, 0037 and 0052, and it appears that “first prescribed time” and “sterilization dwell period” may be referring to the same time period (paras. 0035 and claim 1); however, claim 2 recites “a first prescribed time”, and claim 8 also refer to “the first prescribed time”. Consequently, “a sterilization dwell period” lacks written description support in the original disclosure.
Claims 2-12 and16-20 are rejected because of their dependency on claim 1.
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 8-12, 19 and 20 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.
Claim 8 is amended to recite the limitation "the first prescribed time" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the first prescribed time is referring to the “sterilization dwell period” in claim 1 since the disclosure does not employ the term “sterilization dwell period,” and “sterilization dwell period” in claim 1 appears to be describing the same duration as the “first prescribed time.” Clarification is requested. The examiner notes that claim 2 also recites “a first prescribed time.”
Claims 9-12, 19 and 20 are indefinite because of their dependency on claim 8.
Claim 9 is amended to recite the limitations “the second prescribed time” in line 4 and "the second prescribed amount" in line 6. There is insufficient antecedent basis for these limitations in the claim.
Claims 10-12, 19 and 20 are indefinite because of their dependency on claim 9.
Claim 20 recites the limitation " the amount of waste liquid per measurement " in lines 1-4. This an apparatus claim, but the limitation fails specify which feature of the invention is performing function of calculating the amount of waste liquid per measurement. In addition, “a supply aspiration amount design value”, “a dilution-avoiding aspiration amount”, and “a storage unit of the controller” are not positively recited and thus “a supply aspiration amount design value”, “a dilution-avoiding aspiration amount”, and “a backlash equivalence amount stored in a storage unit of the controller” are arbitrary and thus indefinite. Although para. 0067 states that “the supply aspiration amount design value is a design value of an amount at which the specimen or reagent is aspirated and supplied to the measuring unit 112,” “the dilution avoiding aspiration amount is a design value of a specimen amount aspirated by a dummy in consideration of dilution at the time of dispensing the specimen,” and “the backlash equivalence amount is a value of an error that occurs due to remaining of the specimen or reagent in a dispensing nozzle during dispensing,” it is unclear what are design values, and how these any of these values are obtained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-9 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Lapham (US 20170192030 A1) in view of Satoru (WO 2014119399 A1)(provided in the Applicant’s IDS of 01/25/2022)
Regarding claim 1, Lapham teaches an automatic analyzer (sample processing system 100 and waste management system 1000)(para. 0129, waste management system 1000 may be used with a high-throughput sample processing system, which the examiner interprets the high-throughput sample processing system can be sample process system shown 100 in Fig. 1) comprising:
a measuring assembly (sample processing system 100) that performs an optical measurement of a characteristic of a specimen (interpreted as an intended use. An optical measurement and a specimen are not positively recited. Para. 0059, the sample processing system 100 comprises an analytical device 148, which is a spectrometer, and meets the structural limitation of the intended use), wherein the measuring assembly includes: a light source and a photodetector (a spectrometer has a light source and a photodetector).
a first waste liquid tank (1014) configured to accommodate a waste liquid discharged via a first flow path from the measuring assembly (interpreted as a functional limitation. Fig. 10 and paras. 0128 and 0130 teach 1014 is capable of accommodating a waste liquid from a first flow path, and the waste liquid comes from the sample processing system);
a second waste liquid tank (1016) configured to accommodate a waste liquid discharged via a second flow path from the measuring assembly (interpreted as a functional limitation. Fig. 10 and paras. 0128 and 0130 teach 1016 is capable of accommodating a waste liquid from a second flow path, and the waste liquid comes from the sample processing system);
a valve (1018 or 1020) disposed between the first flow path and the second flow path (Fig. 10) and configured to switch the flow paths so as to discharge the waste liquid to any one of the first waste liquid tank and the second waste liquid tank (interpreted as a functional limitation. para. 0130, valve 1018 or 1020 is capable to directing the flow path by being opened or closed);
a sterilizing agent standby unit (sterilizing solution tank 1032) and configured to hold a sterilizing agent (para. 0131); a valve (valve 1034) fluidically coupled to the sterilizing-agent standby unit; and a feed unit (pump 1038) arranged to feed the sterilizing agent into the first waste liquid tank when driven by the valve (para. 0131); and
a controller (control system) comprising a processor and memory with executable instructions (paras. 0129-0131 and 0134, the control system controls valves to allow fluid flow, determines weight of liquid waste, monitor volumes and pressures to send out allow signals, and terminate the high-throughput sample processing system operation. These functions requires the control system to include a processor and memory with executable instructions), the controller being electrically connected to the valve that switches the first and second flow paths and to the valve that drives the feed unit (control system is electrically connected to the valves as evidenced by the functions the control systems operates toward the valves), wherein the controller is programmed to:
receive a signal from a liquid-level sensor (one of the weight sensors in para. 0131, which teaches weight sensors for determining the amount of liquid in any tank of the waste management system; “liquid-level” is interpreted as an intended use. The weight sensor meets the structural limitation of the intended use) indicating that waste liquid in the first waste liquid tank has reached a first prescribed amount (para. 0131, the control system receive a signal from the weight sensor for determining the amount of liquid in tank 1014, and once a liquid waste tank 1014 is at a predetermined capacity, the flow valve 1018 can be turned off and a sterilizing solution valve 1034 can be opened) that is less than a full capacity of the first waste liquid tank (the examiner interprets the predetermined capacity is less than a full capacity of tank 1014 to prevent overflow of waste liquid, which is common sense);
drive the valve (valve 1034) and the feed unit (pump 1038) to feed the sterilizing agent into the first waste liquid tank (para. 0131) and
drive the electromagnetic valve disposed between the first and second flow paths to close the first flow path and open the second flow path so that subsequent waste liquid is discharged to the second waste liquid tank (para. 0130).
Lapham does not explicitly teach the measuring assembly (sample processing system 100 comprising a spectrometer) includes:
a reaction cell configured to receive the specimen,
(ii) the light source arranged to irradiate the specimen in the reaction cell, and
the photodetector positioned to receive transmitted or scattered light from the specimen.
However, Satoru teaches an automatic analyzer with an analysis unit to analyze a specimen. Satoru further teaches the analysis unit includes a reaction cell (reaction container 5) configured to receive the specimen (lines 130-132, reaction container 5 is capable of holding a specimen), a light source (11) arranged to irradiate the specimen in the reaction cell (Fig. 1), and a photodetector (12) positioned to receive transmitted or scattered light from the specimen (Fig. 1 and lines 36-39),
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the spectrometer of the sample processing system 100 taught by Lapham with a spectrometer that includes a reaction cell, the light source arranged to irradiate the specimen in the reaction cell (Fig. 1) and the photodetector (12) positioned to receive transmitted or scattered light from the specimen as taught by Satoru because one of ordinary skill in the art would accordingly have recognized the spectrometer taught by Satoru would result in the predictable result of providing a spectrometer for analyzing a specimen.
In addition, Lapham teaches the sterilizing agent standby unit is a sterilizing solution tank 1032, but does not teach the shape of the tank, and thus fails to explicitly teach the sterilizing solution tank 1032 is tubular in shape.
However, it has been held that a mere change in shape without affecting the function of the part would have been within the level of ordinary skill in the art, In re Dailey et al. , 149 USPQ 47 (MPEP 2144.04 (IV)(B)). Lapham discloses the sterilizing agent standby unit (sterilizing solution tank 1032) except for the unit formed in a tubular shape. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have construct sterilizing solution tank 1032 in a tubular shape since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in the art when the change in shape is no significant to the function of the combination. Furthermore, one would have been motived to select the shape of tubular (cylindrical) for the purpose of easier to manufacture because solution tank are typically tubular (cylindrical) in shape.
In addition, Lapham though teaches fluidic valves, which is generic, and thus fails to explicitly teach the valve disposed between the first flow path and the second flow path and the valve fluidically coupled to the sterilizing-agent standby unit are electromagnetic valves (valves that are actuated by electromagnetic means).
However, Satoru teaches an automatic analyzer comprises a spectrometer (multi-wavelength photometer 12) with an analysis unit connected to waste liquid tanks (911, 912), such that the waste liquid discharged from the analysis unit is finally held in one of the waste liquid tanks 911 and 921, and a flow path for discharging the waste liquid is connected to each of waste liquid tanks. Satoru further between the waste liquid tanks 911 and 921 and the pipe 901, there is provided a valve 902 for selecting one of waste liquid tanks and blocking the flow paths of the other waste liquid tank. Satoru further teaches the valve is an electromagnetic valve (line 378) and the electromagnetic valve is control by a control unit (line 388).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve in the analyzer system taught by Lapham with an electromagnetic valve taught by Satoru because one of ordinary skill in the art would accordingly have recognized the substitution would have resulted in the predictable results of providing a valve, that can be controlled by a control unit, capable of directing flow to one of the waste liquid tanks and blocking the flow path of the other waste liquid tanks.
In addition, modified Lapham teach the controller is programmed to drive the electromagnetic valve (valve 1034 as modified by Satoru) and the feed unit (pump 1038) to feed the sterilizing agent into the first waste liquid tank (para. 0131), but Lapham is silent with respect to whether the above action happens while the optical measurement of the specimen continues.
However, Lapham teaches automatic analyzer is a high through-put sample processing system with an analysis unit and a waste management system. Lapham teaches the system is fast with a flexible work-flow (Lapham, para. 0039), and many processes can be simultaneously performed (Lapham, para. 0044). In addition, Satoru teaches its analyzer is designed such that the waste liquid retained in the waste liquid tank can be discarded without interrupting the operation (while measurement continues), and thus eliminating time periods during which sample analysis cannot be performed (Satoru, abstract and lns. 550-553).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the program of the control system taught by modified Lapham to simultaneously manage waste (to drive the electromagnetic valve and the feed unit to feed the sterilizing agent into the first waste liquid tank) and process samples (while optical measurement continues), without interrupting the operation as taught by Lapham (Lapham, para. 0039 and 0044) and Satoru (Satoru, abstract, lns. 550-553) in order for the automatic analyzer to be fast in processing and analyzing samples by leveraging the flexible work-flow principle of the system through simultaneously processing sample and managing waste (Lapham, para. 0039 and 0044) and thus eliminating time periods during which sample analysis cannot be performed (Satoru, abstract, lns. 550-553 ) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Lapham would yield the controller is programmed to while the optical measurement of the specimen continues drive the electromagnetic valve (valve 1034 as modified by Satoru) and the feed unit (pump 1038) to feed the sterilizing agent into the first waste liquid tank (simultaneously processing samples while managing waste without interruption during waste management as taught by Lapham (Lapham, para. 0039 and 0044) and Satoru (Satoru, abstract, lns. 550-553)
In addition, modified Lapham the controller is programed to drive the electromagnetic valve (valve taught by Satoru) disposed between the first and second flow paths to close the first flow path and open the second flow path so that subsequent waste liquid is discharged to the second waste liquid tank (para. 0130), but modified Lapham is silent with respect to whether the above action happens after feeding the sterilizing agent and during a sterilization dwell period of the first waste liquid tank.
However, Lapham teaches after feeding the sterilizing agent into a liquid tank, there is an incubation (dwell period) of sterilization, and after the incubation period, the liquid in the waste tank is drained and discard (para. 0133). With this teaching, Lapham discloses that the liquid tank reaches a destinated capacity and ceases to receive further waste at the point when sterilizing agent is fed to the tank. In addition, Satoru teaches an automated analyzer that includes two waste tanks (lns. 366-371). Satoru teaches when it is determined that the waste liquid tank has exceeded the limit liquid level (destinated capacity), the control unit uses the electromagnetic valve 902 to discharge the waste liquid to the other waste liquid tank. (lns. 387 -389). Furthermore, one of ordinary skill in the art to understand that the teaching of Satoru allows for the analyzer to continue operation and prevent waste overflow.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the program of the control system taught by modified Lapham to include the instruction of after feeding the sterilizing agent (Lapham, the point when first liquid tank reaches a destinated capacity) drive the electromagnetic valve disposed between the first and second flow paths to close the first flow path and open the second flow path so that subsequent waste liquid is discharged to the second waste liquid tank (Satoru, switch to a second waste tank when the first one is at capacity) during a sterilization dwell period of the first waste liquid tank (Lapham, para. 0133) as taught by Lapham and Satoru in order to the analyzer to continue operation without waste overflow with a reasonable expectation of success (Satoru, lns. 387-389) (MPEP 2143)(I)(G).
Regarding claim 2, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Lapham further teaches wherein the controller is further configured to discard the waste liquid from the first waste liquid tank after elapse of a first prescribed time since the sterilizing agent is fed into the first waste liquid tank (Lapham, para. 0133)(sterilization dwell time of claim 1 is the predetermined period of time of para. 0133 of Lapham, and “first prescribed time” additionally includes the time it takes to add the sterilizing agent).
Regarding claim 3, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Lapham further teaches the automatic analyzer, wherein the controller is further configured to:
feed the sterilizing agent into the second waste liquid tank (1016) when the waste liquid in the second waste liquid tank reaches a second prescribed amount (para. 0131), and drive the electromagnetic valve (1018 or 1020) to switch the second flow path to close and to switch the first flow path to open (para. 0130).
Regarding claim 4, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 3. Lapham further teaches wherein the controller (control system) is further configured to discard the waste liquid from the second waste liquid tank (1016) after elapse of a second prescribed time since the sterilizing agent is fed into the second waste liquid tank (para. 0133).
Regarding claim 5, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Lapham teaches the automatic analyzer further comprising the sterilizing agent standby unit (sterilizing solution tank 1032) configured to hold the sterilizing agent (para. 0131) as discussed above. Lapham further teaches a sensor configured to detect whether the sterilizing agent is accommodated in the sterilizing agent holding unit (para. 0131, the amount of any tank in the waste management system, including sterilizing solution tank 1032, can be determined using a variety of sensors).
Lapham failed to teach an additional sterilizing agent holding unit configured to accommodate the sterilizing agent.
However, Lapham teaches the claimed invention except for the duplication of the sterilizing agent assembly and the associated sensor.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the sterilizing agent assembly and the associated sensor, since it have been held that a mere duplication of working parts of a device involves only routine skill in the art. Moreover, “mere duplication of parts has no patentable significance unless a new and unexpected result is produced.” In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960) See MPEP 2144.04(VI)(B).
Regarding claim 6, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 1. Lapham further teaches wherein the controller (control system) is further configured to: detect that the waste liquid in the first waste liquid tank (1014) reaches the first prescribed amount (para. 0131 teaches a variety of sensors can be used to determine the amount of waste liquid in 1014, and para. 0134 teaches a control system monitor the volume of 1014. The examiner interpret the control system monitors the volume of 1014 based in a signal from the sensor for determining the amount of liquid in 1014).
Regarding claim 7, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 3. Lapham further teaches wherein the controller (control system) is further configured to:
detect that the waste liquid in the second waste liquid tank reaches the second prescribed amount (para. 0131 teaches a variety of sensors can be used to determine the amount of waste liquid in 1016, and para. 0134 teaches a control system monitor the volume of 1016. The examiner interpret the control system monitor the volume of 1016 based on a signal from the sensor for determining the amount of liquid in 1016).
Regarding claim 8, Lapham in view of Satoru teaches all of the elements of the current invention as stated above with respect to claim 1.
Modified Lapham fails teach wherein the controller is further configured to output a notification to urge a user to discard the waste liquid from the first waste liquid tank after elapse of a first prescribed time since the sterilizing agent is fed into the first waste liquid tank (1014).
However, Lapham teaches after elapse of a predetermined period time since the sterilizing agent is fed into liquid waste tank 1014, drainage valve 1040 opened, allowing the waste to drain from the waste management system 1000 into an appropriate location (para. 0133). Lapham further teaches the control system can signal an alarm (notification) when human intervention is needed (para. 0063).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the controller’s action of opening the drainage valve taught by modified Lapham with signaling an alarm for human intervention taught para. 0063 in Lapham because one of ordinary skill in the art would accordingly have recognized the substitution would have resulted in the predictable results of providing an appropriate action after elapse of a predetermined period time since the sterilizing agent is fed into liquid waste tank.
The teachings of modified Lapham would yield the control unit configured to output a notification to urge a user to discard the waste liquid from the first waste liquid tank after elapse of the first prescribed time (sterilization dwell time of claim 1 is the predetermined period of time of para. 0133 of Lapham, and “first prescribed time” additionally includes the time it takes to add sterilizing agent; see 35 U.S.C. 112(b) above) since the sterilizing agent is fed into the first waste liquid tank.
Regarding claim 9, modified Lapham in view of Satoru teaches all of the elements of the current invention as stated above with respect to claim 8. Modified Lapham further teaches wherein the controller is further configured to feed the sterilizing agent into the second waste liquid tank (1016) when the waste liquid in the second waste liquid tank (1016) reaches a second prescribed amount (predetermined capacity)(para. 0131).
Modified Lapham fails to teach the controller is configured to output a notification to urge the user to discard the waste liquid from the second waste liquid tank after elapse of a second prescribed time since the sterilizing agent is fed into the second waste liquid tank.
However, modified Lapham teaches after an elapse of a predetermined period time since the tablet is fed into liquid waste tank 1016, drainage valve 1042 opened, allowing the waste to drain from the waste management system 1000 into an appropriate location (para. 0133). Lapham further teaches the control system can signal an alarm (notification) when human intervention is needed (para. 0063).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substitute the control system’s action of opening the drainage valve taught by modified Lapham to signaling an alarm for human intervention because one of ordinary skill in the art would accordingly have recognized the substitution would have resulted in the predictable results of providing an appropriate action after elapse of a predetermined period time since the single table is fed into liquid waste tank.
The teachings of modified Lapham would yield the control unit configured to output a notification to urge the user to discard the waste liquid from the second waste liquid tank after elapse of a second prescribed time since the sterilizing agent is fed into the second waste liquid tank.
Regarding claim 17, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Lapham wherein, when a limiting water level sensor detects the liquid level while a warning water level sensor does not detect the liquid level (interpreted as an intended use. A limiting water level sensor and a warning water level sensor are not positively recited. Furthermore, Lapham, para. 0130, a plurality of a variety sensors that meets the limitation of the intended use), the controller is configured to determine an abnormality and end operation (para. 0131).
Modified Lapham fails to teaches the controller is configured to display a warning.
However, Satoru teaches a display unit 20 (Fig. 1) is connected to the computer 18 (Fig. 1). Satoru further discloses that the display unit display message to remind an operator to discard waste liquid in the waste liquid tank (Satoru, lines 214-217).
Therefore, It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller taught by modified Lapham to include the display unit taught by Satoru to display information such as a warning in order to inform an operator when an concern arises with a reasonable expectation of success (Satoru, lines 214-217) (MPEP 2143)(I)(G).
Regarding claim 18, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Lapham further teaches wherein discarding the waste liquid from the first waste liquid tank comprises opening an electromagnetic discharge valve connected to facility piping to drain the sterilized waste liquid (The instant invention is an apparatus, and the process of this claim is interpreted as an intended use. Moreover, para. 0133, open drainage valve to discard liquid waste to drain the waste).
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Lapham et al. (US 20170192030 A1) in view of Satoru et al. (WO 2014119399 A1)(Provided in the Applicant’s IDS of 01/25/2022) as applied claim 9, and further in view of Suchecki et al. (US 6309551 B1).
Regarding claim 10, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 9.
Lapham further teaches if when the user does not discard the waste liquid from the first waste liquid tank (interpreted as if the first waste tank is at a predetermined value because the reason why the liquid tank is the predetermined value (when an user or instrument issues) does not further limit the controller) and the waste liquid in the second waste liquid tank reaches the second prescribed amount, the controller is further configured to (b) suspend the operation of the automatic analyzer (para. 0134)( “suspend the operation” can be for an indefinite amount of time).
Modified Lapham does not explicitly teach, the controller is configured to
calculate a limit time,
(c) if the first waste liquid tank still contains waste liquid after the limit time elapses, end the operation (para. 0134); and to reset the limit time and switch the flow path back to the first waste liquid tank when the waste liquid in the first waste liquid tank is discarded before the limit time elapses.
However, Lapham further teaches signaling an alarm as an alternative to terminating the operation when the first and second waste tank at a predetermined values (para. 0134). In addition Suchecki teaches a system for waste water pretreatment process relating to liquid levels (col. 1, lns. 12-15). Suchecki the system monitors an amount of sterilizing agent available for introduction into a solution to be treated, and activates a first alarm to alert an operator or personnel if the amount falls below a level (a predetermined level)(col. 6, lns. 20-25); activating a second alarm in response to the first alarm remaining activated for an amount of time (claim 5). Suchecki further teaches if a second amount of time elapses following said activating the first alarm or the second alarm with the amount of time below the level (the condition that set off the alarm), system shutoff is activated (claim 7).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the program of the controller taught by Lapham to include measuring a limit time (the duration between activating the first alarm to in initiating system shutoff, the first plus the second amount of time) and to include if the condition that set off the alarm (the first waste liquid tank still contains waste liquid) is still present after the limit time elapses, end the operation as taught by Suchecki in order to allow time for personnel to be notified and intervened (col. 6, lns. 47-48) with a reasonable expectation of success (MPEP 2143)(I)(G).
The teachings of modified Lapham would yield a controller configured to measure a limit time, and if the first waste liquid tank still contains waste liquid after the limit time elapses, end the operation (Suchecki, claims 5 and 7 and Lapham, para. 0134).
Modified Lapham fails to teach the controller is configured to reset the limit time and switch the flow path back to the first waste liquid tank when the waste liquid in the first waste liquid tank is discarded before the limit time elapses.
However, Suchecki teaches if amount of time elapses following said activating the first alarm the predetermined amount of time (limit time) below the level (the condition that set off the first alarm), system shutoff is activated (Suchecki, claim 7 and abstract), which in term teaches that if condition that set off the alarm is no longer present, then the operation continues and the predetermined amount of time (limit time) is reset. In addition, Lapham teaches that when a liquid tank reaches a destinated capacity and it ceases to receive further waste at the point when sterilizing agent is fed to the tank (Lapham, para. 0133 and see also claim 1). In addition, Satoru teaches an automated analyzer that includes two waste tanks (lns. 366-371). Satoru teaches when it is determined that the waste liquid tank has exceeded the limit liquid level (destinated capacity), the control unit uses the electromagnetic valve 902 to discharge the waste liquid to the other waste liquid tank. (lns. 387 -389). Furthermore, one of ordinary skill in the art to understand that the teaching of Satoru allows for the analyzer to continue operation and prevent waste overflow.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the program of the control system taught by modified Lapham to include the instruction of when the condition that set off the alarm is no longer present (when the waste liquid in the first waste liquid tank is discarded before the limit time elapses) to reset the limit time and continue operation (Suchecki, claim 7 and abstract), which involves switch the flow path back to the first waste liquid tank (Satoru, switch to a different waste tank when the other waste tank is at capacity) taught by Lapham, Satoru and Suchecki in order for the analyzer to continue operation when the waste discarding is appropriately handled with a reasonable expectation of success (Satoru, lns. 387-389) (MPEP 2143)(I)(G).
The teachings of modified Lapham would yield to reset the limit time and switch the flow path back to the first waste liquid tank when the waste liquid in the first waste liquid tank is discarded before the limit time elapses.
In addition, modified Lapham teaches the controller is configured to measure the limit time (Suchecki, the duration between activating the first alarm to in initiating system shutoff) but does not teach how the limit time is determined and thus fails to explicitly to teach the controller is configured to calculate the limit time.
However, Suchecki teaches the limit time is predetermined (Suchecki, abstract, claims 5 and 7). Suchecki further teaches for a sufficient amount of time that allows for agent replenishment is determined based on the amount of agent remaining in the agent retainer and the rate the sterilizing agent is depleted from association with the solution to be treated flowing through a chamber (a rate of depletion sterilizing agent)(col. 6 ln. 12-45). Furthermore, a POSITA would recognize with the amount of agent remaining in the agent retainer and the rate the sterilizing agent is depleted, the limited time can be determined by calculation.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller taught by modified Lapham to include calculate limit time as taught by Suchecki in order to determine a limit time with a reasonable expectation of success (Suchecki, col. 6 ln. 12-45 )(MPEP 2143)(I)(G).
Regarding claim 12, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 10.
Modified Lapham further teaches the limit time that is associated with having waste liquid to be discarded or the automatic system would cease in operation as discussed above. Modified Lapham teaches the controller keep tracks of the time elapses (an elapsed time), and once the elapsed time reaches the limit time, the determine if an action (e.g. shutoff) needs to take place (Suchecki, claim 7).
Modified Lapham fails to teach wherein the controller is further configured to a remaining time of display the limit time on a display.
However, Satoru teaches a display unit 20 (Fig. 1) is connected to the computer 18 (Fig. 1). Satoru further discloses that the display unit display message to remind an operator to discard waste liquid in the waste liquid tank (Satoru, lines 214-217). In addition a POSITA would recognize that a remaining time is simply calculated by the subtracting the limit time by the elapsed time.
Therefore, It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controller taught by modified Lapham to include the display unit taught by Satoru to display information such as a remaining time of the limit time, which can be calculated the remaining time based on the limit time and the elapsed time taught by Suchecki (claim 7), in order to inform an operator to discard waste liquid in the waste liquid tank with a reasonable expectation of success (Satoru, lines 214-217) (MPEP 2143)(I)(G).
Claims 11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lapham et al. (US 20170192030 A1) in view of Satoru et al. (WO 2014119399 A1)(Provided in the Applicant’s IDS of 01/25/2022) as applied claim 9, and further in view of Suchecki et al (US 6309551 B1) as applied to claim 10 above, and further in view of Yuji et al. (JP 2011117815 A)(Provided in the Applicant’s IDS of 10/04/2023) and further in view of Elpa et al. (“Automation of mass spectrometric detection of analytes and related workflows: A review.” Talanta, Volume 208, 1 February 2020, 120304.)
Regarding claim 11, modified Lapham teaches the automatic analyzer according to claim 10. Modified Lapham teaches the controller is configured to calculate the limit time.
Lapham teaches a high through-put sample processing and waste management system (abstract). Lapham teaches the system comprising a measuring assembly (sample processing system 100 with a spectrometer) for performing optical measurements, and the second liquid waste tank for receiving waste from the high-throughput sample processing system (para. 0128).
Modified Lapham fails to teach, the controller is configured to calculate the limit time by:
the limit time = (extra capacity of the second waste liquid tank)/ ( number of specimen measurements per unit time x amount of waste liquid per measurement) X safety factor,
wherein the number of specimen measurements per unit time is a rate at which the measuring assembly performs the optical measurement, and
the amount of waste liquid per measurement is an amount of the waste liquid that is utilized to perform the optical measurement.
Lapham also fails to teach how many times the measuring assembly performs the optical measurement per unit time.
However, Yuji et al. (JP 2011117815 A) (Provided in the Applicant’s IDS of 10/04/2023) teaches a liquid chromatograph apparatus and the waste management of the apparatus. Yuji discloses a controller performs calculation based on the capacity of a waste fluid container and the predicted the amount of waste based on the number of samples to determine whether discarding waste is necessary in order to prevent an overflow (paras. 0021 and0023). Yuji teaches a controller that is programmed to calculate the amount of waste will be generated based the number of sample, and predict if the amount of waste will exceed the capacity of a waste fluid container to determine whether discarding waste is necessary before the processing a batch of samples in order to prevent an overflow.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system taught by Lapham with a control system that performs calculation based on the capacity of the waste fluid container (tank 1016 of Lapham) and the predicted the amount of waste based the number samples to determine whether discarding waste is necessary as taught by Yuji in order to prevent an overflow with a reasonable expectation of success (Yuji, para. 0021 0023) (MPEP 2143)(I)(G). The examiner notes that since Yuji teaches the amount of waste based the number samples, it is interpreted the amount of waste per sample is also known.
The teaching of modified Lapham yields the controller calculating the amount of waste that would cause an overflow and determining if discard is necessary prior to a batch of sample to be processed, but does not teach the amount of time it would take for waste to be generated and cause the overflow.
However, modified Lapham teaches the system allows for waste to be managed and discarded while optical measurement continues, and thus have the benefit of eliminate measurement down time during waste management and discard (see above). To leverage the above benefit, a POSITA would recognize the necessary to determine the time it would take for the waste container to be filled (limit time) in order to further help prevent an overflow. Furthermore, a POSITA would recognize the time it takes to fill a container with a liquid is calculated by dividing the capacity of the container to be filled by the rate of the liquid is added to the container. Furthermore, a POSITA would also recognize the benefit to not fill the waster container to a desired fraction instead of full capacity for safety precautions due to unexpected errors or situations.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control system taught by modified Lapham to calculate the time it takes for the waste liquid to fill to a desired fraction of the waste container (limit time) by dividing the capacity of the container desired to be filled “(a scaling factor) X (the capacity of tank 1016)” by the rate of the liquid is added to the container in order to leverage the benefit of eliminating measurement down time during waste management/discard and prevent an waste overflow with safety precautions with a reasonable expectation of success (MPEP 2143)(I)(G).
Modified Lapham does not explicitly teach the rate of the waste liquid is generated and added to the waste container.
However, modified Lapham teaches the amount of waste generated per sample is known (see above, Yuji) In addition, Elpa teaches automation of sample handling and workflows. Elpa teaches evaluation of throughput (whether a system is high, medium or low throughput) is based on samples per hour, e.g. high-throughput, > 60 samples per hour (Elpa, p. 2, right column). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have determined the throughput (samples per hour) of Lapham’s system as taught by Elpa in order evaluate the throughput category (high, medium or low) of Lapham’s system, which Lapham teaches is a high-throughput (abstract). Furthermore, a POSITA would recognize the rate of waste liquid is generated and added to the waste container per hour can be calculate by “(samples per hour) X (an amount of waste liquid per sample)”.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the rate of the liquid is added to the container with the “(samples per hour) X (an amount of waste liquid per sample)” in order to determine the rate the rate of waste liquid is generated and added to the waste container per hour to calculate the limit time to help prevent an waste overflow with a reasonable expectation of success (Ye, abstract) (MPEP 2143)(I)(G).
The teachings of modified Lapham would yield the limit time is calculated by: (extra capacity of the second waste liquid tank X safety factor) or (a scaling factor X the capacity of tank 1016) divided by (a number of specimen measurements per unit time X- amount of waste liquid per measurement) or (sample per hour X an amount of waste liquid per sample; with limit time has an unit of hours).
Regarding claim 19, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 11.
wherein the safety factor is preset in a range from 0.8 to 1.2.
However, modified Lapham teaches the safety factor is a scaling factor that represents a fraction of the volume of the second waste tank (1016), and thus the scaling factor is in a range from 0 to 1.0 (see claim 11).
Therefore, It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the safety factor (scaling factor) to be preset in a range of from 0.8 to 1.0, the portion of modified Lapham’s teaching that corresponds to the claimed range. MPEP 2144.05 (I).
Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Lapham et al. (US 20170192030 A1) in view of Satoru et al. (WO 2014119399 A1)(Provided in the Applicant’s IDS of 01/25/2022) as applied claim 1, and further in view of Ikeda (US 20080008621), further in view of Shimamura et al. (US 4394336 A) further in view of Viessmann (US 3680736 A) and further in view of Elser (US 6450201).
Regarding claim 16, modified Lapham teaches all of the elements of the current invention as stated above with respect to claim 1.
Lapham teaches the sterilizing agent comprises a sterilizing solution, for example bleach solution (para. 0131) and thus Lapham fails to the sterilizing agent comprises sodium dichloroisocyanurate, a hydrate thereof, or sodium trichloroisocyanurate, and is in tablet form.
However, Ikeda teaches chlorine-based sterilizers such as sodium hypochlorite, calcium hypochlorite and sodium dichloroisocyanurate have been known as sterilizers which can be used in various environments (para. 0002). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted bleach solution (sodium hypochlorite) taught by Lapham with sodium dichloroisocyanurate taught by Ikeda because one of ordinary skill in the art would accordingly have recognized the whether bleach or sodium dichloroisocyanurate would result in the predictable result of providing a chlorine-based sterilizers for various environment (para. 0002).
Modified Lapham fails to teach the sodium dichloroisocyanurate is a hydrate and in tablet form.
However, Shimamura teaches a method of producing tablets of sodium dichloroisocyanurate that dissolve gradually and smoothly in water without causing any undesirable collapse and swelling (abstract). Shimamura further sodium dichloroisocyanurate typically come in granules and tablet form with the tablet form having the advantage of ease of transportation, storage and use (col. 1, lns 18-20). Shimamura the sodium dichloroisocyanurate is in a hydrate form (col 2, lns. 12-26)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sodium dichloroisocyanurate taught by Lapham to be a hydrate and in tablet form as taught by Shimamura in order to have a sodium dichloroisocyanurate that dissolve gradually and smoothly and are easy to store, transport and use with a reasonable expectation of success (Shimamura, abstract and col. 1, lns. 18-20) (MPEP 2143)(I)(G).
In addition, the sterilizing solution tank 1032 (sterilizing agent standby unit taught in claim 1) of Lapham is configured for sterilizing solution and may not be suitable for sterilizing agent that is in tablet form.
However, Viessmann (US 3680736 A) teaches a dispenser for dispensing sterilizing agent tablet (abstract, col. 1, lns. 16-20). Viessmann teaches the dispenser (positioned above the body of water (col. 1, lns 56-67), wherein dispenser (the sterilizing agent hopper assembly) includes a storage compartment (tubular hopper)(Fig. 1) that stores a plurality of solid sterilizing tablets (4)(Fig. 1), and a rotary valve (3) arranged at a lower end of the dispenser (Fig. 1) to release a single tablet from hopper so that the tablet falls by gravity (Fig. 1, col. 1, lns. 2-7 and lns. 50-64). Viessmann teaches that mechanism for rotating a rotatory valve is known in the art (Viessmann, col. 2, lns. 48-50), and thus does not disclose the actuation mechanism of the rotary valve. However, Elser teaches a rotary valve and the used of electromagnet as a means for actuating the rotary valve (Elser, col. 2, lns. 15-17).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the valve 1034 (electromagnetic valve), pump 1038 (feed unit) and sterilizing solution tank 1032 (sterilizing agent standby unit) taught by modified Lapham with the dispenser comprising tubular compartment 5 configured to hold a sterilizing agent (Fig. 1), a rotary valve fluidically coupled to the sterilizing-agent standby unit; and a feed unit (dispensing duct 2) taught by Viessmann in order to store and dispense the sterilizing tablets with a reasonable expectation of success (Viessmann, col. 1, lns. 2-7 and lns. 50-64) (MPEP 2143)(I)(G).
Moreover, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the actuation mechanism for the rotary valve taught by Viessmann with a means that comprises electromagnet taught by Elser because one of ordinary skill in the art would accordingly have recognized that a means that comprises an electromagnet would result in the predictable result of providing an actuation mechanism for the rotary valve (Elser, col. 2, lns. 15-17).
The teachings of Lapham as modified by Viessmann further modified by Elser would yield a sterilizing agent standby unit (Viessmann, storage compartment 5) formed in a tubular shape (Viessmann Fig. 1) and configured to hold a sterilizing agent (Fig. 1); an electromagnetic valve (rotary valve of Viessmann as modified by Elser) fluidically coupled to the sterilizing-agent standby unit (Fig. 1); and a feed unit (Viessmann dispenser duct 2) arranged to feed the sterilizing agent into the first waste liquid tank when driven by the electromagnetic valve (Lapham, para. 0131).
Prior art
Claim 20 is not being treated with prior art. MPEP 2173.06(II) states, "where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In reSteele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims." This is the case here and the examiner points to the rejection of claim 20 under 112(b) supra.
Response to Arguments
Applicant’s arguments, see p. 9, filed 2/2/2026, with respect to claim objections have been fully considered and are persuasive. The claim objects of 10/03/2025 has been withdrawn.
Applicant’s arguments, see pp. 9-12, filed 2/2/2026, with respect to the rejection(s) under 35 U.S.C. 112(a) have been fully considered and are persuasive. Therefore, the rejections under 35 U.S.C. 112(a) of 10/03/2025 have been withdrawn.
The examiner notes that with respects to the written description of the "limit time" calculation, the specification does provide written description support. However, there are indefinite issues associated with the calculation of “the amount of waste liquid per measurement.” It is unclear what “a supply aspiration amount design value”,” a dilution-avoidance aspiration amount”, and “a backlash equivalence amount stored by the controller” are. Para. 0067 discloses that “the supply aspiration amount design value is a design value of an amount at which the specimen or reagent is aspirated and supplied to the measuring unit 112,” “the dilution avoiding aspiration amount is a design value of a specimen amount aspirated by a dummy in consideration of dilution at the time of dispensing the specimen,” and “the backlash equivalence amount is a value of an error that occurs due to remaining of the specimen or reagent in a dispensing nozzle during dispensing;” however, it is unclear what the design values represent (are they instrument specific?), and how any of these values are obtained. Therefore, it necessitates a new ground of rejection under 35 U.S.C. 112(b).
The rejections under 35 under 35 112(b) of 10/03/2025 also have been withdrawn in view of the amendments. However, new grounds of rejection is by the amendments.
Applicant’s arguments, see pp. 14-19, filed 02/02/2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered. The Applicants argues that the coordinated features of the claims are not taught or suggested by the cited art either alone or in combination. The Applicant presented the following arguments broken down by prior art references.
In the arguments presented on p. 15 and p. 18 relating to the teachings of Lapham and Satoru, the Applicant argues on p. 15 that Lapham and Satoru do not teach the claimed continuous-measurement, feed-then-switch sequence tied to a sterilization dwell and timed discard required in claim 1. On p. 18, the Applicant further argues that there are “no articulated motivation supports modifying Lapham/Satoru to perform Applicant's coordinated dosing-while-measuring and switch-for- dwell sequence or the analyzer-rate-based forecast.” More specifically, the Applicant argues that “[T]he Office Action's suggestion that one would "program the system" to release sterilant while optical measurement continues because high throughput is desirable is conclusory.” Furthermore, the Applicant argues that Lapham/Satoru does not address the amended features of “specific choreography now claimed: trigger at the first prescribed amount, dosing during ongoing optical measurement, immediate post-dose path switching to the other tank to establish a defined dwell, discard after a prescribed dwell time, and a controller-computed capacity forecast bound to the analyzer's optical-measurement rate and waste per measurement with a displayed countdown.”
The examiner respectfully disagrees. As explained in the Office Action of 10/03/2025, Lapham teaches a high through-put system that is designed to be fast, with a flexible work-flow (para. 0039), and many processes can be simultaneously performed (para. 0044). Therefore, a POSITA would be motivated to simultaneously manage waste and process sample (feeding sterilizing agent into the first waste tank while optical measurement continue) in order for the system to be fast by leveraging the flexible work-flow. In addition, the modification is further motivated by the teaching of Satoru, which teaches its analyzer is designed such that the waste liquid in the waste liquid tank can be discarded without interrupting the operation, and thus eliminating time periods during which sample analysis cannot be performed (abstract and lns. 550-553). Therefore, a POSITA would be motivated to manage waste without interrupting the operation in order to for the system to be fast and efficient by eliminating time period during which sample analysis cannot be performed. Therefore, the motivation to modify the Lapham’s controller to drive the electromagnetic valve and the feed unit to feed the sterilizing agent into the first waste liquid tank while optical measurement continues is well supported by the teachings of both Lapham and Satoru, and not conclusory. In addition, Lapham in view of Satoru does teach the controller features in the amended claim 1, and Lapham in view of Satoru in view of a combination of Suchecki, Yuji and/or Elpa does teach the controller features in the amended dependent claim as discussed above in the 35 U.S.C. 103 section. Therefore this argument is not persuasive.
In the arguments presented on p. 15 relating to the teachings of Viessmann and Elser, the Applicant argues that the disclosed dosing architecture: a tubular sterilizing-agent standby (holding) unit, an electromagnetic metering valve fluidically coupled to that unit, and a feed unit arranged to feed sterilant into the tank when the valve is driven is materially different from a rotary, gravity-tablet dispenser taught by Viessmann and Elser. In addition, the Applicant further argues that Viessmann/Elser's hopper hardware onto Lapham/Satoru would still not yield the controller-synchronized feed-then-switch sequence required by the claims.
The examiner respectfully disagrees. It is first noted that claim 1 recites an electromagnetic valve not a electromagnetic metering valve, and a metering valve is not recited in an of the claims. In any case, Viessmann as modified by Elser does teach the architecture of tubular sterilizing-agent standby (holding) unit (Viessmann, storage compartment 5), an electromagnetic valve (rotary valve of Viessmann as modified by Elser, which modifies the rotary to be actuated electromagnetically) fluidically coupled to that unit (Fig. 1 of Viessmann), and a feed unit (Viessmann, dispenser duct 2) arranged to feed sterilant into the waste tank of Lapham when the valve is driven as discussed under claim 16 in the 35 U.S.C. 103 above. Furthermore, the teachings of Viessmann/Elser's hopper hardware is not relied upon to yield the recited functions of the controller in claim 1, which is taught by Lapham in view of Satoru as discussed above. Therefore, this argument is not persuasive.
The arguments presented on p. 16 relating to the teachings of Oku have been considered but are moot because the new ground of rejection does not rely on Oku applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In the arguments presented on pp. 16-17 relating to the teachings of Yuji, the Applicant argues Yuji does not disclose “computing a tank-capacity-based limit time using the specific variables recited in claim 11-namely extra capacity ÷ (optical-measurement rate x waste per optical measurement) x safety factor-nor does it disclose displaying a remaining-time countdown derived from that computation and using it to control suspend/end behavior.” In addition, the Applicant argues that Yuji is silent on the controller choreography in claim 1 and thus does not cure the deficiencies of Lapham, Satoru, Viessmann, Elser, or Oku.
The examiner respectfully disagrees. Yuji alone is not relied upon to teach claim 11, it is the teaching of Yuji in combination of Lapham, Satoru, Suchecki and Elpa that teaches the limitations of claim 11. More specifically, calculating the limit time based on extra capacity ÷ (optical-measurement rate x waste per optical measurement) x safety factor is taught by Lapham, Satoru, Suchecki, Yuji and Elpa as discussed in the 35 U.S.C. 103 section above, with Yuji discloses a controller performs calculation based on the capacity of a waste fluid container and the predicted the amount of waste based on the number of samples to determine whether discarding waste is necessary in order to prevent an overflow (paras. 0021 and0023). Furthermore, claim 11 does not require “displaying a remaining-time countdown derived from that computation and using it to control suspend/end behavior.” Finally, the teachings of Yuji is not relied upon to yield the recited functions of the controller in claim 1, which is taught by Lapham/Satoru as discussed above. Therefore, this argument is not persuasive.
In the arguments presented on pp. 17-18 relating to the teachings of Talanta, the Applicant argues Talanta automation analytical workflow, not address the features of the claims listed on top of p. 18, and thus cannot supply the missing elements or provide a reasoned motivation to modify Lapham/Satoru toward Applicant's claimed solution.
The examiner respectfully disagrees. Elpa (Elpa is the author listed first in the cited article published in the Journal Talanta) does provide teachings on automation analytical workflow, which is applicable to Lapham’s automated analytical system (paras. 0004, 0059 and 0061). Specifically, Elpa provides guidelines on how to categorize whether an automated system is high, medium or low through-put based on the number of samples the system can process per hour, and thus provide a motivation for Lapham to determine the system throughput (sample per hour) as discussed in claim 11 of 35 U.S.C. 103 section above. Therefore, this argument is unpersuasive.
(The arguments presented on p. 18 relating to the teachings of Lapham/Satoru is discussed above with the argument associated with Lapham/Satoru).
The arguments presented on pp. 18-19 with respect to rejections of claims 10-12 under 35 U.S.C. 103 have been fully considered and are persuasive. The claim rejections of 10/03/2025 has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Lapham, Satoru, Suchecki, Yuji, and/or Elpa.
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758