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 comprising claims 1 – 15 in the reply filed on 12/17/2025 is acknowledged.
Claims 16 – 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/17/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: in line 4, the term “to” should be inserted prior to the word “process.” Appropriate correction is required.
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 4, 5, 13 and 15 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.
Regarding claim 4, in line 2, the phrase “… a first module of the one or modules … “ is unclear and is therefore considered indefinite.
Regarding claim 13, in line 3, the phrase “… change the operational state a first module of the one or more modules to disabled, … “ is unclear. Similarly, in line 9, the phrase “… change the operational state a second module of the one or more modules to enabled, … “ is unclear, and is therefore considered indefinite.
Regarding claim 15, in line 15, the phrase “… in response the second instructions … “ is unclear and is therefore considered indefinite.
Note Regarding Prior Art
Examiner cites particular sections, columns, line numbers, paragraphs and figures, in the references as applied to the claims below for the convenience of the Applicant. Although the specified citations are representative of the teachings in 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 that, in preparing responses, the Applicant fully consider the references in their 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.
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.
(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.
Claim(s) 1 – 15 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Schmidt (US 2020/0243171 A1; hereinafter “Schmidt”).
Regarding claim 1, Schmidt teaches throughout the publication a method of controlling a diagnostic laboratory system, comprising:
providing one or more modules, each of the one or more modules configured to process a specimen container and/or analyze a specimen (routing samples to be tested by a laboratory instrument (controlling a diagnostic laboratory system) by executing software modules to schedule tests (or modules) for analyzing a sample of a patient (or specimen); paragraphs 15, 20, 50 and 67);
providing middleware configured to communicate with the one or more modules (middleware that routes the sample to, or communicates with, the instrument using the software module; paragraph 57), wherein the middleware is configured to generate instructions to change an operational state of at least one of the one or more modules to at least enabled or disabled (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change the operational of the modules to disabled; paragraphs 12, 66, 67 and 70; figure 6; claim 6);
generating, by the middleware, one or more instructions to change the operational state of at least one of the one or more modules (middleware provides signals or instructions if the presently ordered tests are to be canceled (change the operational state of the modules); paragraph 70); and
changing the operational state of at least one of the one or more modules in response to one or more instructions generated by the middleware (canceling the test order (changing the operational state of the modules) based on the signaling provided by the middleware hub performing the steps (instructions) in figure 6; paragraphs 66 and 83).
PNG
media_image1.png
705
525
media_image1.png
Greyscale
Regarding claim 2, Schmidt teaches the method of claim 1, wherein providing one or modules comprises providing one or more modules configured to process a specimen container and one or more modules configured to analyze a specimen (e.g., paragraphs 20, 26, 29 and 57).
Regarding claim 3, Schmidt teaches the method of claim 1, wherein:
the middleware is configured to generate instructions to change the operational state of at least one of the one or more modules to enabled, disabled, and sleep (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change the operational state of the modules to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6);
generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of at least one of the one or more modules to enabled, disabled, or sleep (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change the operational state of the modules to disabled; figure 6; paragraphs 12, 66, 67 and 70; claim 6); and
changing the operational state of at least one of the one or more modules comprises changing the operational state of at least one of the one or more modules to enabled, disabled, or sleep in response to one or more instructions generated by the middleware (canceling the test order (i.e., changing the operational state of the modules) based on the signaling provided by the middleware hub performing the steps or instructions in figure 6; paragraphs 66 and 83).
Regarding claim 4, Schmidt teaches the method of claim 1, comprising receiving a status of a first module of the one or more modules (determining whether the current test order is ideal (the current status of the first module); paragraphs 82 and 83; figure 6) and wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the first module in response to the status of the first module (the middleware provides signals or instructions if the presently ordered tests are to be canceled (i.e., change the operational state of the first module) after step 606 (i.e., the status of the first module); figure 6; paragraph 70).
Regarding claim 5, Schmidt teaches the method of claim 4, wherein receiving a status of the first module comprises receiving a status indicating that at least one parameter of the first module is outside a predetermined threshold (determining that the current test order is not ideal or indicating a parameter is outside a predetermined threshold; figure 6; paragraphs 82 and 83) and wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the first module to disabled (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change an operational state of the first module to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6).
Regarding claim 6, Schmidt teaches the method of claim 1, wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change an operational state of at least one of the one or more modules depending on a time of day (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change an operational state of the modules) based on time of collection, or time of day; figure 6; paragraphs 12, 66, 67, 70 and 73; claim 6).
Regarding claim 7, Schmidt teaches the method of claim 1, wherein one of the one or more modules is a laboratory analyzer (middleware or module includes software modules for analyzing test results; paragraphs 15 and 57) and further comprising running a quality control test on the laboratory analyzer (the middleware module or analyzer determines quality indicators for quality control; paragraph 56), wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the laboratory analyzer in response to at least one result of the quality control test (canceling the test order or changing the operational state of the analyzer based on the signaling provided by the middleware hub and sample quality indicator, such as via a control test; figure 6; paragraphs 56, 66 and 83).
Regarding claim 8, Schmidt teaches the method of claim 7, wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the laboratory analyzer to disabled (the middleware hub performs tasks during processing cycles (or instructions) to cancel a scheduled task at step 614 (or changes an operational state of the analyzer to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6) in response to a predetermined number of results of the quality control test from the laboratory analyzer being outside of a predetermined threshold (i.e., using individually performed quality control results for different test levels with the threshold limit set parameters (results of the quality control test being outside of a predetermined threshold); paragraphs 57 and 64).
Regarding claim 9, Schmidt teaches the method of claim 7, wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the laboratory analyzer to disabled (the middleware hub performs tasks during processing tasks or instructions to cancel a scheduled test at step 614 (i.e., change an operational state of the analyzer to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6) in response to a predetermined number of results of the quality control test of the laboratory analyzer being outside of a predetermined threshold during a predetermined time period (i.e., using individually performed quality control results for different test levels with threshold limit set parameters (i.e., results of the quality control test being outside of a predetermined threshold) during the time collection for each sample or time period; paragraphs 57; 64 and 73)).
Regarding claim 10, Schmidt teaches the method of claim 7, wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change the operational state of the laboratory analyzer to disabled (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change an operational state of the analyzer to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6) in response to a plurality of consecutive results of the quality control test of the laboratory analyzer being outside a predetermined threshold (i.e., using individually performed quality control results for different test levels with threshold limit set parameters (consecutive results of the quality control test being performed outside of a predetermined threshold) during the time of collection for each sample; paragraphs 57, 64 and 73).
Regarding claim 11, Schmidt teaches the method of claim 1, comprising:
generating, by the middleware, one or more instructions to change the operational state a first module of the one or more modules to disabled (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change the operational state of a first module to disabled); figure 6; paragraphs 12, 66, 67 and 70; claim 6); and
routing specimen containers to bypass the first module in response to the operational state of the first module being disabled (i.e., routing samples or specimen containers to be tested by a laboratory instrument after canceling the scheduled test (i.e., bypass the first module in response to the operational state); paragraphs 15, 20, 50 and 67).
Regarding claim 12, Schmidt teaches the method of claim 1, comprising: generating, by the middleware, one or more instructions to change the operational state a first module of the one or more modules to enabled (the middleware hub performs tasks during processing cycles or instructions to create a test order (i.e., change the operational state of a first module to enabled); figure 6; paragraphs 12, 66, 67, 70 and 92; claim 6); and
routing specimen containers to the first module in response to the operational state of the first module being enabled (i.e., routing samples or specimen containers to be tested by a laboratory instrument after creating the test order (i.e., the first module in response to the operational state); paragraphs 15, 20, 50 and 67).
Regarding claim 13, Schmidt teaches the method of claim 1, comprising:
generating, by the middleware, one or more instructions to change the operational state of a first module of the one or more modules to disabled (the middleware hub performs tasks during processing cycles or instructions to cancel a scheduled test at step 614 (i.e., change the operational state of a first module to disabled); figure 6; paragraphs 12 ,66, 67, 70; claim 6), wherein the first module is configured to perform at least a first process on specimen containers or specimens when the operational state of the first module is enabled (i.e., routing samples to be tested by a laboratory instrument (i.e., perform a first process on specimens) by executing software modules to schedule tests for analyzing a sample of the patient after creating the test order (i.e., the first module is enabled); paragraphs 15, 20, 50, 67 and 92);
generating, by the middleware, one or more instructions to change the operational state of a second module of the one or more modules to enabled (the middleware hub performs tasks during processing cycles or instructions to create a test order (i.e., change the operational state of a second module to enabled); figure 6; paragraphs 12, 66, 67, 70 and 92; claim 6), wherein the second module is configured to perform at least the first process on specimen containers or specimens when the operational state of the second module is enabled (i.e., routing samples to be tested by a laboratory instrument (i.e., perform a first process on specimens) by executing software modules to schedule tests for analyzing a sample of the patient after creating the test order (i.e., the second module is enabled); paragraphs 15, 20, 50, 67 and 92); and
performing the first process on specimen containers and/or specimens using the second module (i.e., routing samples to be tested by a laboratory instrument using a first process by executing software modules to schedule tests for analyzing a sample of the patient after creating the test order using the second module; paragraphs 15, 20, 50, 67 and 92).
Regarding claim 14, Schmidt teaches the method of claim 1, comprising:
providing a laboratory information system in communication with the middleware (sending the result of the reflex test from the middleware to a laboratory information system (LIS); claim 17), wherein the laboratory information system is configured to schedule processing on the one or more modules (LIS 102 system makes available the new orders (i.e., schedule processing on the modules); paragraph 71), wherein generating, by the middleware, one or more instructions comprises generating, by the middleware, one or more instructions to change an operational state of at least one of the one or more modules in response to scheduling by the laboratory information system (i.e., middleware provides signals or instructions of the presently ordered tests are to be canceled (i.e., change the operational state of the modules) when the new tests are made available by the LIS 102 (i.e., response to scheduling); paragraphs 70 and 71).
Regarding claim 15, Schmidt teaches the method of claim 1, wherein providing one or more modules comprises providing a master module and one or more submodules in communication with the master module (i.e., executing software modules to schedule tests using the master module for managing medical testing with other functional modules embedded in software modules (i.e., submodules in communication); paragraphs 15, 19, 20, 50, 66 and 67);
providing middleware comprises providing middleware configured to communicate with the master module (middleware routes the samples to the instrument using the software module or master module; paragraph 57);
generating, by the middleware, one or more first instructions to change an operational state of at least one of the master module or the one or more submodules (middleware p0rovides signals or first instructions if the presently ordered tests are to be canceled (i.e., change the operational state of the submodules); paragraph 70);
transmitting the first instructions to the master module (the middleware hub communicates with the software module or master module to perform tasks during processing cycles by receiving the associated data set identified to invoke the rules engine at step 604 (i.e., transmitting the first instructions); figure 6; paragraphs 12, 66, 67, 70 and 70; claim 6);
generating, by the master module, second instructions to change the operational state of at least one of the master module or the one or more submodules (the middleware hub executes the software module or master module that performs tasks during processing cycles or second instructions to cancel a scheduled test at step 614 (i.e., change the operational state of the master module) after step 604; figure 6; paragraphs 12, 66, 67 and 70; claim 6); and
changing the operational state of at least one of the master module or the one or more submodules in response to the second instructions (i.e., canceling the test order (i.e., changing the operational state of the submodules) based on the signaling provided by the middleware hub performing the steps in figure 6 (i.e., the second set of instructions); figure 6; paragraphs 66 and 83).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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.
BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796
Prosecution Insights