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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/02/2024 is being considered by the examiner.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“liquid level detection element” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In this instant case, the corresponding structure for
the “liquid level detection element” is an element that detects the liquid level by a change in capacitance (para. 0113), and equivalents thereof.
Claim Rejections - 35 USC § 112
.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-6 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 2 recites the limitation “the other one of the fluid control valves” in line 7. It is unclear which valves it is referring to because there are two or more of the first fluid control valves (line 2).
Claims 3 and 4 also recites “the other one of the fluid control valves” in lines 2 and 4 and in lines 2 and 4 with the same indefinite issues as discussed above.
Claim 5 recites the limitation "a difference between the positions of the liquid level detected by the liquid level detection element" in 11. It is unclear which positions “the positions” are referring to because “a position” is recited in claim 1, lines 6, 14, and 21 and claim 5, lines 3 and 5. Specification appears to suggest that the positions are referring to the positions in claim 5 (paras. 0056-0063). Clarification and corresponding amendment is requested. It is suggested that the position be clearly identified in the recitation (e.g., first position, second position, etc.)
Claim 5 recites the limitation recites “another one of the fluid control valves” in line 6 and “the other one of the fluid control valves” in line 9. It is unclear whether they are referring to the same valve. It appears to be they are the same valve based on paras. 0056-0063, and that if they are different valves, then it is unclear how the normality of “the other one of the fluid control valves” is based on the positions results from opening and closing two other valves. However, the claim does recite two or more of the second fluid control valve, so it is possible that they are referring to different valves. Clarification is requested. It is suggested that the valves be clearly identified in the recitation (e.g., first second fluid control valve, second second fluid control valve, etc.)
Claim 6 also recites “the other one of the fluid control valves” in lines 5 and have the same indefinite issues as discussed above.
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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sagae et al (WO 2020085055 A1)(references herein made with respect to English equivalent found at US 20220034930 A1) in view of Kondo (JP-2010-217147)(provided in the Applicant IDS of 05/02/2024) and in view of Yokota et al. (WO-2020066449)(references herein made with respect to English equivalent found at US 20220034929)(provided in the Applicant IDS of 05/02/2024).
Regarding claim 1, An automated analysis device (Fig. 1) comprising:
a flow path (the flow path of automated analyzer as shown in Fig. 1)(paras. 0034-0035 syringe 18 and disc 1 create a flow path connecting a number of dispensing mechanisms including 7, 8 and 11) which feeds liquid;
a plurality of fluid control valves (valves 51, dispensing mechanisms 7 and 8 each has a valve 51)(para. 0042, dispensing mechanism 7 and 8 each has a liquid-surface sensing mechanism as shown in Fig. 3) which are placed in the flow path and switch between opening and closing of the flow path(para. 0046);
a liquid level detection element (electrostatic capacitance detecting unit 58, Fig. 3) which detects a position of a liquid level of a liquid (para. 0049); and
a control unit (computer 21)(Figs 2 and 3 control unit 57, and para. 0045, control unit 57 is configured as part of computer 21),
one or more of the fluid control valves (valve 51 for mechanisms 7) act as a second fluid control valve connected to a discharge nozzle (probe 7a) through the flow path;
the liquid level detection element detects a position of a liquid level of a liquid discharged from the discharge nozzle (paras. 0010-0011, 0014 and 0049, sensing a liquid surface level);
Sagae teaches a sample dispensing mechanism 11, but fails to teach the details of the structures that are connected to mechanism 11, and thus fails to teach a pressure sensor (53, Fig. 2) which measures pressure in the flow path; and wherein one or more of the fluid control valves act as a first fluid control valve connected to the pressure sensor through the flow path.
However, Kondo teaches an automated analysis system comprising a sample dispensing mechanism (abstract, Fig. 1). Kondo teaches the sample dispensing mechanism comprises a pressure sensor (9) which measures pressure in the flow path (para. 0020); and wherein one or more of the fluid control valves act as a first fluid control valve (check valve 7 and solenoid valves 8) connected to the pressure sensor through the flow path.
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 sample dispensing mechanism 11 taught by Sagae with the sample dispensing mechanism in Fig. 1 of Kondo as taught by Kondo because one of ordinary skill in the art would accordingly have recognized the sample dispensing mechanism of Kondo would result in the predictable result of providing a sample dispensing mechanism in an automated analyzer with structural details, and simple substitution of one known element (sample dispensing mechanism 11 of Sagae) for another element (sample dispensing mechanism of Fig. 1 of Konda) is likely to be obvious when predictable results (dispensing mechanism for automated analyzer) are achieved. See MPEP 2143(I)(B).
The teaching of modified Sagae would yield the automatic analysis device comprising a pressure sensor (Kondo, pressure sensor 9) which measures pressure in the flow path; wherein one or more of the fluid control valves (in addition to valves 51 of mechanisms 7 and 8 of Sagae, modified Sagae also includes valves 7 and 8 of Kondo) acts as a first fluid control valve (Kondo, valves 7 and 8) connected to the pressure sensor through the flow path (Konda, Fig. 1).
Modified Sagae further teaches the control unit (Sagae, para. 0045, computer 21) detects whether or not the first fluid control valve has normally operated based on a value of the pressure measured by the pressure sensor (Sagae, para. 0045, and Kondo, para. 0029)
Sagae teaches the control unit (computer 21) detects whether or not the liquid sucking at the reagent dispensing probe has normally operated based on a position of the liquid level detected by the liquid level detection element (para. 0050), but fails to explicit teaches whether the abnormal aspiration is caused by the second control valve and thus fails to the control unit (computer 21) detects whether or not the second fluid control valve (valve 51 of mechanism 7) has normally operated based on a position of the liquid level detected by the liquid level detection element.
However, Yokota teaches an automated analysis system comprising a valve and a liquid level detection element (liquid detection sensor 102b, Fig. 7) which detects a position of a liquid level of a liquid (Fig. 8 and para. 0085, step 801); a control unit (controller 115), a fluid control valve (second fluid valve) connected to a discharge nozzle (the opening of 212). Yokota further teaches the control unit detects whether or not the second fluid control valve has normally operated based on a position of the liquid level detected by the liquid level detection element (para. 0085) as outlines in the algorithm in Fig. 8.
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 computer 21 taught by Sagae to include algorithms that follows the logic described in Fig. 8 of Yokota to determine whether the valve (second fluid control valve) is functioning properly (Yokota, Fig. 8, para. 0085) based a position of the liquid level detected by the liquid level detection element (Fig. 8, S801) as taught by Yokota to detects whether or not the second fluid control valve is the cause of abnormal aspiration with probe because such modified would enable the determination the aspiration abnormality is caused by the second fluid valve (Yokota, para. 0085) with a reasonable expectation of success (MPEP 2143)(I)(G).
Regarding Claim 2, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Sagae further teaches the analysis device comprising two or more of the first fluid control valves (Kondo, valves 7 and 8). With regards to the limitation, “wherein in a state where among the first fluid control valves one of the fluid control valves is opened, the control unit opens and closes another one of the fluid control valves, acquires a value of the pressure measured by the pressure sensor, and detects whether or not the other one of the fluid control valves has normally operated based on the acquired value of the pressure”, it is a conditional limitation. Since the invention is an apparatus, the claims does not require the above condition to be met, and thus the limitation associated with the condition is not required.
For compact prosecution, modified Sagae teaches wherein in a state where among the first fluid control valves one of the fluid control valves (check valve 7) is opened, the control unit opens and closes another one of the fluid control valves (electromagnetic valve 8), acquires a value of the pressure measured by the pressure sensor (9)(para. 0020 and 0025, measurement at t1), and detects whether or not the other one of the fluid control valves (valve 7) has normally operated based on the acquired value of the pressure (Yokota, Fig. 2 and para. 0029, scenario 3, when check valve 7 is not closed, the control unit opens and close valve 8 during T2, and detects valve 7 is abnormal).
Regarding Claim 3, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Sage further teaches wherein in the flow path in which the other one of the fluid control valves among the first fluid control valves is placed, a flow rate when the other one of the fluid control valves is opened is larger than a predetermined value (the flow rate is larger than the predetermined value, which is an arbitrary value that is destinated to be lower than the flow rate).
Regarding claim 4, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 2. Modified Sagae further teaches wherein the control unit detects whether or not the other one of the fluid control valves (7) has normally operated based on an amplitude of a change in the pressure after the other one of the fluid control valves is opened and closed (Kondo, Fig. 2 and para. 0029).
Regarding claim 5, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 1. Sagae teaches the device comprising two or more of the second fluid control valves (Sagae, valves 51 of dispensing mechanism 7 and 8), wherein the liquid level detection element (electrostatic capacitance detecting unit 58) detects a position of the liquid level after one of the fluid control valves among the second fluid control valves is opened and closed, and then detects a position of the liquid level after another one of the fluid control valves among the second fluid control valves is opened and closed (para. 0049-0052, electrostatic capacitance detecting unit 58 detects liquid levels when one or both valves 51 are opened and/or closed),
Modified Sagae teaches the control unit (computer 21) detects whether or not the other one of the fluid control valves has normally operated based on a difference between the positions of the liquid level detected by the liquid level detection element (Sagae, para. 0051, computer 21 judges abnormality based on liquid levels, which necessitated comparing/calculating a difference between positions; and Yokota, para. 0033 and Fig. 3, determines abnormality caused by which valve).
Regarding claim 6, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 5. Sagae further teaches wherein the liquid discharged by opening and closing the one of the fluid control valves among the second fluid control valves and the liquid discharged by opening and closing the other one of the fluid control valves among the second fluid control valves are different from each other (interpreted as an intended use. valves 51 meets the structural limitation of the intended use), and the liquid level detection element detects a position of the liquid level of a mixed liquid of the liquids different from each other after the other one of the fluid control valves is opened and closed (interpreted as an intended use. Electrostatic capacitance detecting unit 58 meet the structural limitation of the intended use).
Regarding claim 7, modified Sagae teaches all of the elements of the current invention as stated above with respect to claim 1.
Sagae teaches an automated analyzer for analyzing sample such as blood or urine (para. 0034). Sagae teaches the analysis device comprises a plurality of stations with dispensing mechanisms and detectors (Fig. 1, paras. 0037, 56), but fails to a station with a detection unit which analyzes a reaction liquid which is a mixed solution of a sample and a reagent wherein one or more of the fluid control valves act as a third fluid control valve connected to the detection unit through the flow path, a syringe is connected to the flow path connecting the detection unit and the third fluid control valve, 61 the syringe aspirates the reaction liquid and feeds the reaction liquid to the detection unit, and the control unit detects whether or not the third fluid control valve has normally operated based on a detection result of the reaction liquid by the detection unit.
However, Yokota teaches an automated analyzer for analyzing sample such as blood or urine. Yokota further teaches the analyzer station for detecting abnormality of an electromagnetic valve, wherein the station (Fig. 4) comprising a detection unit (detector) which analyzes a reaction liquid which is a mixed solution of a sample and a reagent (para. 0055), wherein a third fluid control valve (104) connected to the detection unit through the flow path, a syringe (103) is connected to the flow path connecting the detection unit and the third fluid control valve (104), the syringe aspirates the reaction liquid and feeds the reaction liquid to the detection unit (para. 0053), and the control unit detects whether or not the third fluid control valve has normally operated based on a detection result of the reaction liquid by the detection unit (Fig. 5).
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 analyzer taught by Sagae to include the station (Yokota, Fig. 4) comprising a detection unit (Yokota, detector) which analyzes a reaction liquid which is a mixed solution of a sample and a reagent (Yokota, para. 0055), wherein a third fluid control valve (Yokota, 104) connected to the detection unit through the flow path, a syringe (Yokota, 103) is connected to the flow path connecting the detection unit and the third fluid control valve (Yokota, 104), the syringe aspirates the reaction liquid and feeds the reaction liquid to the detection unit (Yokota, para. 0053), and the control unit detects whether or not the third fluid control valve has normally operated based on a detection result of the reaction liquid by the detection unit (Yokota, Fig. 5) as taught by Yokota in order to provide a means for detecting abnormality of an electromagnetic valve with a reasonable expectation of success (Yokota, abstract) (MPEP 2143)(I)(G). The claimed limitation are obvious because all the claimed elements were known in the prior and one skilled in the art could have combined the elements as claimed by know methods with no change in their respective functions and the combination yield nothing more than predictable results (an automated analyzer for with valve abnormality detection). See MPEP 2143 (I)(A).
Conclusion
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/M.L.C./ Examiner, Art Unit 1758
/MARIS R KESSEL/ Supervisory Patent Examiner, Art Unit 1758
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