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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shimase et al (US PGPub 2014/0377132), cited on the IDS.
Regarding Claim 1, Shimase et al teaches an automatic analyzer (as illustrated in Figure 1) comprising:
a cleaning tank (referred to as sample nozzle cleaning tank 110 or reagent nozzle cleaning tank 111) in which cleaning using a detergent (i.e. cleaning water) is performed with analysis operation of a specimen (see [0037]-[0038]); and
a waste fluid pipe (referred to as vent 11) through which a waste fluid flowing from the cleaning tank is discharged, wherein: the waste fluid pipe has an upward pipe (i.e. vent 11a) branched upward; at a tip end of the upward pipe, opening is provided; and the opening is disposed below the cleaning tank (see Figures 8-10 and [0085]-[0086]).
Furthermore, it is noted that the limitation, “cleaning using a detergent” is being viewed as an intended use limitation, and while features of an apparatus (i.e. the automatic analyzer) may be recited either structurally or functionally, "[A]pparatus claims cover what a device is, not what a device does and [i]nclusion of the material or article worked upon (i.e. the detergent) by a structure being claimed does not impart patentability to the claims. See MPEP 2114 and 2115.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mori et al (US PGPub 2019/0339296).
Regarding Claim 1, Mori et al teaches an automatic analyzer (as illustrated in Figure 1 and see [0008]) comprising:
a cleaning tank (referred to as one or more of cleaning tank 13, 30, 31, 32 or 33) in which cleaning using a detergent (i.e. cleaning water) is performed with analysis operation of a specimen (see [0030], [0033], [0036] and [0038]);
a waste fluid pipe (referred to as waste liquid pipes 37, 40 or 41 ) through which a waste fluid flowing from the cleaning tank is discharged, wherein: the waste fluid pipe has an upward pipe (i.e. waste liquid pipe 41) branched upward; at a tip end of the upward pipe, opening is provided; and the opening is disposed below the cleaning tank (see Figures 2-3 and [0039]-[0043]).
Furthermore, it is noted that the limitation, “cleaning using a detergent” is being viewed as an intended use limitation, and while features of an apparatus (i.e. the automatic analyzer) may be recited either structurally or functionally, "[A]pparatus claims cover what a device is, not what a device does and [i]nclusion of the material or article worked upon (i.e. the detergent) by a structure being claimed does not impart patentability to the claims. See MPEP 2114 and 2115.
Regarding Claim 9, Mori et al teaches that the opening is provided with a cap (i.e. a solenoid valve, SV1 or SV2) that opens when the waste fluid is brought into contact with the cap (see [0043]-[0044]). Furthermore, it is noted that while features of an apparatus (i.e. the automatic analyzer) may be recited either structurally or functionally, "[A]pparatus claims cover what a device is, not what a device does and [i]nclusion of the material or article worked upon (i.e. the detergent) by a structure being claimed does not impart patentability to the claims. See MPEP 2114 and 2115.
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) 2, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (or Shimase et al) as applied to claim 1 above, and further in view of Durrant et al (US PGPub 2018/0172563).
Regarding Claims 2 and 5, neither Shimase et al nor Mori et al explicitly discloses that a tray is provided around the upward pipe and that the tray is connected to a tank.
However, in the analogous art of cleaning composition systems, Durrant et al teaches cleaning compositions, which may help to reduce or prevent the precipitate from forming (and possibly depositing a solid film on the surfaces it contacts, e.g., surfaces in an automated stainer machine, e.g., drain lines, waste trays or reservoirs, valves, etc.) (see [0021]). Furthermore, Durrant et al teaches a waste system for a batch stainer may have a mechanism in place for removing hematoxylin solution from the hematoxylin reservoir used for staining (such as a drainage valve in the reservoir or vacuum nozzle on, in, or in proximity to the hematoxylin reservoir), while a hematoxylin waste system for an individual sample stainer may have a mechanism for removing the hematoxylin solution directly from the biological sample (such as a vacuum nozzle in proximity to the biological sample) and/or for removing the hematoxylin solution from a waste storage area in the stainer system (such as a drainage valve on a drip tray or other device for capturing used hematoxylin solution during the staining process or a vacuum nozzle on, in, or in proximity to such device) (see [0031]). In addition, Durrant et al teaches that solution in the waste tray was evacuated into the waste reservoir. In this way, the cleaning composition was introduced into the waste reservoir. There, the cleaning solution can help to prevent the formation of precipitate or reduce the amount of precipitate (see [0089]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the waste system of Mori et al (or Shimase et al) by further incorporating a waste tray below the waste tank (as taught by Durrant et al) for the benefit of enabling waste (from the waste tank) to be effectively collected and exposed to cleaning composition in order to prevent the formation of precipitate or reduce the amount of precipitate.
Regarding Claim 8, Shimase et al teaches that the waste fluid pipe (vent 11) is split into a high waste fluid pipe (i.e. vent 11a) through which a high waste fluid containing the specimen is discharged and a low waste fluid pipe (i.e. vent 11b) through which a low waste fluid other than the high waste fluid is discharged (see Figure 9 and [0086]).
In addition, Mori et al teaches that the waste fluid pipe (as described above) is split into a high waste fluid pipe (i.e. waste liquid pipe 37) through which a high waste fluid containing the specimen is discharged and a low waste fluid pipe (i.e. waste liquid pipe 41) through which a low waste fluid other than the high waste fluid is discharged (see Figure 2a-c and [0039]-[0041]).
However, neither Shimase et al nor Mori et al teaches that a tray is provided around the upward pipe of the low waste fluid pipe; and the tray is connected to a high waste fluid arrangement to which the high waste fluid pipe is connected.
However, in the analogous art of cleaning composition systems, Durrant et al teaches cleaning compositions, which may help to reduce or prevent the precipitate from forming (and possibly depositing a solid film on the surfaces it contacts, e.g., surfaces in an automated stainer machine, e.g., drain lines, waste trays or reservoirs, valves, etc.) (see [0021]). Furthermore, Durrant et al teaches a waste system for a batch stainer may have a mechanism in place for removing hematoxylin solution from the hematoxylin reservoir used for staining (such as a drainage valve in the reservoir or vacuum nozzle on, in, or in proximity to the hematoxylin reservoir), while a hematoxylin waste system for an individual sample stainer may have a mechanism for removing the hematoxylin solution directly from the biological sample (such as a vacuum nozzle in proximity to the biological sample) and/or for removing the hematoxylin solution from a waste storage area in the stainer system (such as a drainage valve on a drip tray or other device for capturing used hematoxylin solution during the staining process or a vacuum nozzle on, in, or in proximity to such device) (see [0031]). In addition, Durrant et al teaches that solution in the waste tray was evacuated into the waste reservoir. In this way, the cleaning composition was introduced into the waste reservoir. There, the cleaning solution can help to prevent the formation of precipitate or reduce the amount of precipitate (see [0089]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the waste system of Mori et al (or Shimase et al) by further incorporating a waste tray below and connected to the high waste fluid arrangement to which the high waste fluid pipe is connected (as taught by Durrant et al) for the benefit of enabling waste (from the waste tank) to be effectively collected and exposed to cleaning composition in order to prevent the formation of precipitate or reduce the amount of precipitate.
Claim(s) 2, 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (or Shimase et al) as applied to claim 1 above, and further in view of Middleton-Davis et al (US PGPub 2016/0161476).
Regarding Claims 2 and 5, neither Shimase et al nor Mori et al explicitly discloses that a tray is provided around the upward pipe and that the tray is connected to a tank.
However, in the analogous art of modular fluid dispensing devices, Middleton-Davis et al teaches liquid dispensing devices, wherein the liquid dispensing devices comprise a wash buffer reservoir, at least one reagent reservoir, multiple reservoir control valves, an optional central pump, an electronic control board, a reaction vessel that comprises one or more baffles, a waste tray, and a motorized cam (see [0023]). The waste tray serves as a chamber into which the fluid from the reaction vessel drains. The waste tray can be of any shape and size, but is generally designed to hold from about 100 ml to about 2000 ml, from about 150 ml to about 1500 ml, from about 200 to about 800 ml, or from about 250 ml to about 400 ml of fluid. In some embodiments, the waste tray comprises a port, which serves as an opening into which the fluid from the reaction vessel (through the second port thereof) can enter the waste tray and the waste tray is in fluid communication with the reaction vessel by tubing (see [0031]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the waste system of Mori et al by further incorporating a waste tray below the waste tank (as taught by Middleton-Davis et al) for the benefit of enabling waste (from a tank, such as the cleaning tank) to be effectively collected and removed as needed.
Regarding Claim 8, Shimase et al teaches that the waste fluid pipe (vent 11) is split into a high waste fluid pipe (i.e. vent 11a) through which a high waste fluid containing the specimen is discharged and a low waste fluid pipe (i.e. vent 11b) through which a low waste fluid other than the high waste fluid is discharged (see Figure 9 and [0086]).
In addition, Mori et al teaches that the waste fluid pipe (as described above) is split into a high waste fluid pipe (i.e. waste liquid pipe 37) through which a high waste fluid containing the specimen is discharged and a low waste fluid pipe (i.e. waste liquid pipe 41) through which a low waste fluid other than the high waste fluid is discharged (see Figure 2a-c and [0039]-[0041]).
However, neither Shimase et al nor Mori et al teaches that a tray is provided around the upward pipe of the low waste fluid pipe; and the tray is connected to a high waste fluid arrangement to which the high waste fluid pipe is connected.
However, in the analogous art of modular fluid dispensing devices, Middleton-Davis et al teaches liquid dispensing devices, wherein the liquid dispensing devices comprise a wash buffer reservoir, at least one reagent reservoir, multiple reservoir control valves, an optional central pump, an electronic control board, a reaction vessel that comprises one or more baffles, a waste tray, and a motorized cam (see [0023]). The waste tray serves as a chamber into which the fluid from the reaction vessel drains. The waste tray can be of any shape and size, but is generally designed to hold from about 100 ml to about 2000 ml, from about 150 ml to about 1500 ml, from about 200 to about 800 ml, or from about 250 ml to about 400 ml of fluid. In some embodiments, the waste tray comprises a port, which serves as an opening into which the fluid from the reaction vessel (through the second port thereof) can enter the waste tray and the waste tray is in fluid communication with the reaction vessel by tubing (see [0031]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the waste system of Mori et al by further incorporating a waste tray below and connected to the high waste fluid arrangement to which the high waste fluid pipe is connected (as taught by Middleton-Davis et al) for the benefit of enabling waste (from a tank, such as the cleaning tank) to be effectively collected and removed as needed.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) as applied to claim 2 above, and further in view of Muz et al (US PGPub 2022/0057422 ).
Regarding Claims 3-4, Shimase et al teaches that operating mechanisms of the automatic analyzer are all controlled by a computer via a communication device and an interface (see [0049]).
In addition, Mori et al teaches that mechanisms of the automatic analyzer are connected to and is controlled by and is controlled by the controller 21 (see [0033]) and that he light intensity measured by the spectrophotometer 4 is transmitted to the controller 21 through an A/D converter and an interface. In the controller 21, for example, the concentration or the like of a predetermined component of an analysis item corresponding to the reagent is calculated from the absorbance of the liquid mixture (reaction solution) (see [0035]).
However, neither Shimase et al nor Mori et al in combination with Durrant et al (or Middleton-Davis et al) teaches a water leakage sensor that detects water leakage is provided in the tray; wherein the control unit notifies detection of water leakage by the water leakage sensor.
However, in the analogous art of automatic analyzers, Muz et al teaches an automatic analyzer system which comprises a leak detector 38 used to detect the overflowing of the mixing tank 11. It can, for example, be designed as a capacitive leak sensor. The leak detector 38 can optionally be connected to the electronic measuring and control system 15 and can be designed to send a signal to the electronic measuring and control system 15 if said leak detector 38 detects fluid escaping from the gas supply line 23. Based upon this signal, the electronic measuring and control system 15 can output a warning or alarm signal (see [0041]). It would have been obvious to one of ordinary skill in the art to modify the automatic analyzer systems of the combination of Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) by further incorporating a leak detector 38 (acting as a leak sensor) in the waste tray and having the control unit notify detection of water leakage by the water leakage sensor (as taught by Muz et al) for the benefit of effectively detecting overflow from the cleaning tank and then displaying a warning or alarm signal to users of the automatic analyzer system.
Claim(s) 3-4 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (or Shimase et al) as applied to claim 1 above, and further in view of Saetvet et al (US PGPub 2019/0214242).
Regarding Claims 3-4, Shimase et al teaches that operating mechanisms of the automatic analyzer are all controlled by a computer via a communication device and an interface (see [0049]).
In addition, Mori et al teaches that mechanisms of the automatic analyzer are connected to and is controlled by and is controlled by the controller 21 (see [0033]) and that he light intensity measured by the spectrophotometer 4 is transmitted to the controller 21 through an A/D converter and an interface. In the controller 21, for example, the concentration or the like of a predetermined component of an analysis item corresponding to the reagent is calculated from the absorbance of the liquid mixture (reaction solution) (see [0035]).
However, neither Shimase et al nor Mori et al in combination with Durrant et al (or Middleton-Davis et al) teaches a water leakage sensor that detects water leakage is provided in the tray; wherein the control unit notifies detection of water leakage by the water leakage sensor.
However, in the analogous art of automatic sampling systems, Saetvet et al teaches a digestion system 104, which generally includes a sample input stream 200, a digestion vessel 202, an agitation system 204, a temperature control system 206, an overflow outlet 208, a secondary overflow outlet 210, an acid input 212, a deionized water input 214, a level sensor 216, and a digested sample outlet 218. In implementations, the cutoff valve 120 controls the flow of sample from the sample input 102 to the sample input stream 200. The volume of sample introduced to the digestion system 104 can be controlled by the volume of the digestion vessel 202, where excess sample can be removed via the overflow outlet 208 and/or the secondary overflow outlet 210. In implementations, the secondary overflow outlet 210 includes a leak sensor to monitor flow of fluid through the secondary overflow outlet 210 from the digestion vessel 202 (see [0017]). It would have been obvious to one of ordinary skill in the art to modify the automatic analyzer systems of the combination of Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) by further incorporating a leak sensor in the waste tray and having the control unit notify detection of water leakage by the water leakage sensor (as taught by Saetvet et al) for the benefit of effectively monitoring flow of excess (unneeded) fluid that overflows from the cleaning tank.
Regarding Claims 6-7, Shimase et al teaches that operating mechanisms of the automatic analyzer are all controlled by a computer via a communication device and an interface (see [0049]).
In addition, Mori et al teaches that mechanisms of the automatic analyzer are connected to and is controlled by and is controlled by the controller 21 (see [0033]) and that he light intensity measured by the spectrophotometer 4 is transmitted to the controller 21 through an A/D converter and an interface. In the controller 21, for example, the concentration or the like of a predetermined component of an analysis item corresponding to the reagent is calculated from the absorbance of the liquid mixture (reaction solution) (see [0035]).
However, neither Shimase et al nor Mori et al in combination with Durrant et al (or Middleton-Davis et al) teaches a water level sensor that measures a liquid level height in the tank, wherein when a liquid level height in the tank reaches a first water level, the control unit stops reception of a new specimen and continues analysis operation of a received specimen; and when a liquid level height in the tank reaches a second water level higher than the first water level, the control unit stops the analysis operation.
However, in the analogous art of automatic sampling systems, Saetvet et al teaches a digestion system 104, which can include the level sensor 216 at a specific height of the digestion vessel 202 to halt operation of the syringe pump 226 upon detection by the level sensor 216 of a particular level of liquid present in the digestion vessel 202. In implementations, the level sensor 216 can include, but is not limited to, an optical sensor, a capacitive sensor, or combinations thereof (see [0018]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the automatic analyzer systems of the combination of Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) by further incorporating a level sensor measuring the height of liquid/fluid present in the cleaning tank (as taught by Saetvet et al) for the benefit of enabling the user to effectively be alerted when the level of liquid present in the tank is either too low or too high and thus start or halt operation of the automatic analyzer (i.e. stop or start flow of liquid into the tank).
Claim(s) 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) as applied to claim 5 above, and further in view of Yan et al (US PGPub 2020/0300880).
Shimase et al teaches that operating mechanisms of the automatic analyzer are all controlled by a computer via a communication device and an interface (see [0049]).
In addition, Mori et al teaches that mechanisms of the automatic analyzer are connected to and is controlled by and is controlled by the controller 21 (see [0033]) and that he light intensity measured by the spectrophotometer 4 is transmitted to the controller 21 through an A/D converter and an interface. In the controller 21, for example, the concentration or the like of a predetermined component of an analysis item corresponding to the reagent is calculated from the absorbance of the liquid mixture (reaction solution) (see [0035]).
However, neither Shimase et al nor Mori et al in combination with Durrant et al (or Middleton-Davis et al) teaches a water level sensor that measures a liquid level height in the tank, wherein when a liquid level height in the tank reaches a first water level, the control unit stops reception of a new specimen and continues analysis operation of a received specimen; and when a liquid level height in the tank reaches a second water level higher than the first water level, the control unit stops the analysis operation.
However, in the analogous art of waste liquid treatment apparatus and sample analyzers, Yan et al teaches a waste liquid treatment apparatus 200 (201) further comprising a liquid level sensor 215 (as shown in FIG. 7) disposed inside each waste liquid chamber 21. The controller 221 is further connected to each liquid level sensor 215. Each liquid level sensor 215 is used for sensing a liquid level height inside the waste liquid chamber 21 in which the liquid level sensor is located (see [0063]). Specifically, for each waste liquid chamber 21, the controller 221 is configured for controlling, when a liquid level height in the waste liquid chamber 21 sensed by the liquid level sensor 215 in the waste liquid chamber is greater than a first preset height, the pressure supply device 30 to temporarily stop supplying negative pressure to the waste liquid chamber 21 within the negative pressure period of the waste liquid chamber 21, such that the waste liquid chamber 21 temporarily stops collecting a waste liquid. The first preset height may be set as a safety height that prevents a waste liquid from running into the vent 2122. In other embodiments, the first preset height may be set as a safety height that prevents a waste liquid from overflowing from the waste liquid chamber 21. In other embodiments, the controller 221 may be further configured for controlling, when the liquid level height is greater than the first preset height, the pressure supply device 30 to supply positive pressure to the waste liquid chamber 21 within the negative pressure period of the waste liquid chamber 21, such that the waste liquid chamber 21 discharges a waste liquid (see [0067]). Accordingly, it would have been obvious to one of ordinary skill in the art to modify the automatic analyzer systems of the combination of Mori et al (or Shimase et al) and Durrant et al (or Middleton-Davis et al) by further incorporating a level sensor measuring the height of liquid/fluid present in the cleaning tank (as taught by Yan et al) for the benefit of enabling the user to effectively be alerted when the level (i.e. height) of liquid present in the tank is either too low or too high and thus start or halt operation of the automatic analyzer (i.e. stop or start flow of liquid into the tank by stopping or starting pressure to the tank).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Shimase et al as applied to claim 1 above, and further in view of Yan et al (US PGPub 2020/0300880).
Regarding Claim 9, Shimase et al does not teach that the opening is provided with a cap that opens when the waste fluid is brought into contact with the cap.
However, in the analogous art of waste liquid treatment apparatus and sample analyzers, Yan et al teaches a sample analyzer system, wherein during waste liquid treatment, when the negative pressure channel of the control valve 222-1 is opened, the waste liquid chamber 21-1 is in communication with a negative pressure air opening of the pressure supply device 30 and is disconnected from a positive pressure air opening of the pressure supply device. The inside of the waste liquid chamber 21-1 is in a negative pressure state, and the negative pressure state enables the waste liquid chamber 21-1 to collect waste liquids in the waste liquid pipes 1 to 4. Meanwhile, the positive pressure channel of the control valve 222-2 is opened. The waste liquid chamber 21-2 is disconnected from the negative pressure air opening of the pressure supply device 30 and is in communication with the positive pressure air opening of the pressure supply device. The inside of the waste liquid chamber 21-2 is in a positive pressure state, and the positive pressure state enables a waste liquid in the waste liquid chamber 21-2 to be discharged through the liquid outlet 2111 of the waste liquid chamber 21-2 into the outside (see [0049]). It would have been obvious to one of ordinary skill in the art to modify the analyzer system of Shimase et al by providing a cap (such as a control valve, taught by Yan et al) in the opening for the benefit of enabling fluid flow through the opening to be effectively controlled.
Conclusion
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797