DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-19 are presented for examination. Claims 15-19 are withdrawn from consideration.
Applicant’s election without traverse of claims 1-14 in the reply filed on 7/30/26 is acknowledged.
The title of the invention is not descriptive. A new title is required that is
clearly indicative of the invention to which the claims are directed.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/23 was considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
6. Claim 2 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 thermal profile” in line 5. There is insufficient antecedent basis for these limitation in the claim.
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 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.
7. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
8. Claims 1, 2, 4, 5, 7-9, 11, 13 and 14 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Knafel (Knafel), US publication no. 2012/0109531 A1.
As per claim 1, Knafel teaches a method for optimizing sample distribution in a laboratory system [figure 8], the method comprising:
retrieving, at a control unit of the laboratory system, one or more test requests for each sample provided to the laboratory system [para 159];
controlling, by the control unit, a transport system [conveyor line 112] of the laboratory system to convey the provided samples to one or more sample buffer units [136, figure 1; para 159];
creating, by the control unit, run instructions [instruction 144; para 157-160] based on optimization criteria to run one or more requested tests on selected samples on a test plate [sample holder] [based on a query response 198 of a query 194, cf. para. [0160], taking into account e.g. an updated processing status, cf. para. [0134-135], that takes into account malfunctions etc., or number of samples added after the start of processing etc., cf. para. [0139]];
transmitting, by the control unit, the run instructions to an analyzer [146, figure 1] of the laboratory system [para 157]; and
controlling, by the control unit, the transport system to convey the selected samples, for which one or more requested tests are identified to be executed, from a sample buffer unit to the analyzer [figure 8; para 129, 143].
Knafel teaches:
[0143] In another embodiment the sample workflow manager may provide multiple preconfigured processing routes to the instrument manager in accordance with the process status. The sample workflow manager may provide preconfigured processing routes for commonly or pre-specified types of samples. The sample workflow manager may also provide preconfigured processing routes for previously used types of test orders. The instrument manager may be configured for selecting one of the multiple preconfigured processing routes in accordance with the test order. For example, the instrument manager may select a preconfigured processing route which routes the biological sample to a sequence of analysis system components which are able to perform all the tests specified in the test order.
[0157] The third analysis system component 108 comprises an analyzer 146. The analyzer 146 is for analyzing or measuring a physical property of the biological sample 114. The analyzer 146 is connected to a processor 138 which is connected to a computer-readable storage medium 140. The computer-readable storage medium contains a program 142 and instructions 144 received from the instrument manager
104. The processor 138 uses the program 142 for controlling the operation of the analyzer 146. The instructions 144 are used by the program 142 to generate specific commands to the analyzer 146. The third analysis system component 108 is
essentially an analyzer.
[0159] The instrument manager 104 comprises a processor 160 and a computer-readable storage medium 162. The computer-readable storage medium 162 contains a program 164 which is used to control the operation of the instrument manager 104. The computer-readable storage medium 162 also contains a test order 166 which the instrument manager 104 either received via a network connection, an email, input by
an operator or was automatically generated when the biological sample 114 was placed into the analysis system 100. The test order 166 is used by the program 164 to initiate analysis of the biological sample 114 by the analysis system 100. The computer-readable storage medium 162 also contains a preconfigured process route 168. The preconfigured process route 168 may be received from the sample workflow manager
102. The computer-readable storage medium 162 also contains a command generation module 170. The command generation module 170 is computer executable code which
uses the preconfigured process route 168 to generate the instructions 134, 144, 154 used by the analysis system components 106, 108, 110. The computer-readable storage medium 162 also contains a sample tracking message 172 which may be received from one of the analysis system components 106, 108, 110, 112. The sample tracking message 172 contains data which indicates the physical location and/or
process status of the biological sample 114.
As per claim 2, Knafel teaches the optimization criteria are selected from one or more of: a test request for samples already present in the sample buffer and/or in the system; a test request for samples already present in the analyzer; [para 134, 135, 159]; an availability of the analyzer [para 108, 130]; and one or more user specific preferences [figure 3; para 162]; a number and type of controls to be used on a test plate; a ratio of samples/controls present on a test plate; the thermal profile of the requested test; an amount of a reagent loaded on the analyzer; an expiration time/date of a reagent loaded on the analyzer; an expiration time/date of the sample; a time of day; a cost for a test; a target time for a test result to be delivered; a resting time of a sample in the laboratory system; a travel time of a sample between two specific locations of the laboratory system.
As per claim 4, Knafel teaches receiving, by the analyzer, the selected samples;
for each of the received samples, transmitting, by the analyzer, information to the control unit that the sample has been received by the analyzer; updating, by the control unit, a run status of the analyzer with the information received by the analyzer [para 134-135, 138].
As per claim 5, Knafel teaches transmitting, by the control unit, updated run instructions to the analyzer to run the one or more selected tests with the samples received by the analyzer when the number of samples received by the analyzer is less than the number of samples conveyed to the analyzer [figure 8; para 134-135, 160, 167].
As per claim 7, Knafel the test plate is a multi-well-plate comprising a plurality of wells arranged in rows and columns, and wherein the run instructions comprise
instructions to arrange in a row of the test plate only selected samples and/or controls for a requested test [figure 8; para 124-135, 160-161].
As to claims 8, 9, 11, 13 and 14, contained the same limitations as claims 1, 2, 4, 5 and 7. Therefore, it is rejected on the same basis as set forth hereinabove.
Allowable Subject Matter
9. Claims 3, 6, 10 and 12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
10. The following is a statement of reasons for the indication of allowable subject matter: the prior art of records do not teach: in claims 3 and 10, comparing, by the control unit, the created run instructions with the analyzer specific run instructions; determining, by the control unit, a difference between the created run instructions and the analyzer specific run instructions; creating, by the control unit, updated run instructions based on optimization criteria and the determined difference between the created run instructions and the analyzer specific run instructions; transmitting, by the control unit, the updated run instructions to the analyzer. In claims 6 and 12, generating, by the control unit, a prompt provided to a user to check the analyzer if the number of samples received by the analyzer is less than the number of samples conveyed to the analyzer.
11. Examiner's note: Examiner has cited particular paragraphs and columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. MPEP 2141.02 VI: “PRIOR ART MUST BE CONSIDERED IN ITS ENTIRETY, INCLUDING DISCLOSURES THAT TEACH AWAY FROM THE CLAIMS."
12. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Eberhardt et al., US publication no. 2014/0129172 A1, teaches a method comprising: generating, by at least one processor using a workflow management layer, a process plan for a sample in a sample container; providing the process plan to a process control layer; determining, by the at least one processor using the process control layer, an optimized route consistent with the process plan; and processing the sample using the optimized route.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHUN CAO whose telephone number is (571)272-3664. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kamini Shah can be reached on 571-272-2279. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHUN CAO/Primary Examiner, Art Unit 2115
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