DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I: Claims 1-9 in the reply filed on 19 AUGUST 2026 is acknowledged.
Claim 10 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 19 AUGUST 2026.
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 12 MARCH 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 08 MAY 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 2 and 4 are objected to because of the following informalities: There are formulas at the end of each of the claims with no explanation. In addition, there is no period at the end of claims if the formula are to part of the claim language. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by JPH03-172764 A, SHIMADZU, submitted on the Information Disclosure Statement on 12 MARCH 2024, Foreign Patent Documents No. 1.
Applicant’s invention is directed to an analyzer.
Regarding Claim 1, the SHIMADZU discloses an automatic analyzer, Figure 1, Claim 1, [0001], comprising:
an operation terminal, Figure 1, data processing section 18, abstract, [0001];
an analyzer having an active examination function of executing, in parallel with an initial examination, Figure 1, detection unit 17, [0001], a re-examination possibly required after the initial examination on the same specimen, Claim 1; and
a computer configured to communicate with the analyzer, Figure 1, control section 9, [00001], wherein the computer is configured to execute determination processing as to whether an analysis time is shorter when the active examination function is enabled than when the active examination function is disabled based on performance data of an examination executed in the past, and output determination data of the determination processing to the operation terminal or the analyzer, Figure 1, Claim 1, [0001], (Operation).
Regarding Claim 2, the SHIMADZU discloses the automatic analyzer of Claim 1. The instant claim language is directed to a conditional limitation and is interpreted under the broadest reasonable interpretation to required only that structure must occur if the condition is met. Since the invention is directed toward an apparatus what is only required is the structure of performing the function must be present. In addition, the instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. The automatic analyzer according to claim 1, wherein if a transport time per specimen is T1, a reaction time per specimen is T2, a dispensing time per specimen is T3, the number of analyses in the initial examination is N1, and the number of analyses in the re-examination is N2, the computer determines that the analysis time is shortened when the active examination function is enabled if the following conditional expression is satisfied, and determines that the analysis time is not shortened even when the active examination function is enabled if the conditional expression is not satisfied. T1+T2+T3 x (N2+1)>T3 xN1x2. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Similarly, regarding Claim 3, the SHIMADZU discloses the automatic analyzer of Claim 1. The instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). The automatic analyzer according to claim 2, wherein the number of analyses in the re-examination is an expected value calculated, based on the performance data, from a ratio of analyses that transition to the re-examination after the initial examination, [0001].
Regarding Claim 4, the SHIMADZU discloses the automatic analyzer of Claim 1. The instant claim language is directed to a conditional limitation and is interpreted under the broadest reasonable interpretation to required only that structure must occur if the condition is met. Since the invention is directed toward an apparatus what is only required is the structure of performing the function must be present. In addition, the instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. The automatic analyzer according to claim 1, wherein if a transport time per specimen is T1, a reaction time per specimen is T2, a dispensing time per specimen is T3, the number of analyses in the initial examination is N1, and the number of analyses in the re-examination is N2, the computer determines that the analysis time is shortened when the active examination function is enabled if both of the following two conditional expressions are satisfied, and determines that the analysis time is not shortened even when the active examination function is enabled if at least one of the two conditional expressions is not satisfied. T1+T2+T3 x (N2+1)>T3 xN1x2T1+T2>T3x(N1-1). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Similarly, regarding Claim 5, the SHIMADZU discloses the automatic analyzer of Claim 4. The instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). The automatic analyzer according to claim 2, wherein the number of analyses in the re-examination is an expected value calculated, based on the performance data, from a ratio of analyses that transition to the re-examination after the initial examination, [0001].
Regarding Claim 6, the automatic analyzer according to claim 1, wherein the computer is configured to output a recommendation setting of the active examination function to the operation terminal as the determination data, page 3, [0001], analysis conditions are changed according to instructions, and the computer outputs the recommendation setting of recommending to enable the active examination function to the operation terminal if it is determined in the determination processing that the analysis time is shortened by enabling the active examination function, and outputs the recommendation setting of recommending to disable the active examination function to the operation terminal if it is determined in the determination processing that the analysis time is not shortened even by enabling the active examination function, page 3, [0001], analysis conditions are changed according to instructions and displayed on display unit 19.
Regarding Claim 7, the automatic analyzer according to claim 1, wherein the computer is configured to output an enabling command for enabling the active examination function or a disabling command for disabling the active examination function to the analyzer as the determination data, page 3, [0001], analysis conditions are changed according to instructions also Instruct the patient to perform both the analysis using the analysis conditions and the analysis using the retest analysis conditions, and the computer outputs the enabling command to the analyzer if it is determined in the determination processing that the analysis time is shortened by enabling the active examination function, and outputs the disabling command to the analyzer if it is determined in the determination processing that the analysis time is not shortened even by enabling the active examination function, page 3, [0001], instructions are displayed on display unit 19.
Regarding Claim 8, the automatic analyzer according to claim 1, wherein the computer uses learned data obtained by machine learning based on the performance data, calculates analysis times when the active examination function is enabled and when the active examination function is disabled based on analysis request data, and executes the determination processing. The instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Regarding Claim 9, the automatic analyzer according to claim 1, wherein the computer uses learned data obtained by performing machine learning on a data set included in the performance data, the data set including a specimen ID, a test name, whether the active examination is executed, and a time required for an analysis of the specimen ID, calculates analysis times when the active examination function is enabled and when the active examination function is disabled based on the specimen ID and the test name, and executes the determination processing. The instant claim language is directed towards a method of how the computer is intended to be used and operated and does not further define the analyzer structurally. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
Prosecution Insights