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
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 – 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Olson et al. (US 2019/0331703 A1; “Olson”).
Regarding claim 1, Olson teaches a method for processing a blood sample contained in a container in a test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C), the method comprising:
setting a clotting start time for the blood sample and/or the container (e.g., the set period of time is intended to match the clotting time; paragraph 47);
setting a clotting wait time to allow the blood sample to clot (the staging module 40 is configured to hold multiple sample containers 90 for a set period of time. Typically, the set period of time is sufficient to allow the blood in the sample container to further clot; paragraph 40); and
c) on positive determination of completion of the clotting wait time, automatically providing the blood sample to a centrifuge coupled to the test system (the staging module 40 can release the sample container to one of the storage compartments 19a, 19b or to the centrifugation module 70; paragraph 41), wherein a time of a withdrawal of the blood sample into the container is obtained from a sample related data source, and wherein at least one statement from the following group of statements is true:
i) the clotting start time is set as the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47); and
ii) the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47).
Regarding claim 2, Olson teaches the method as claimed in claim 1, wherein the clotting start time is set as at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 25, 44 and 47); and
b) a time of loading the container containing the blood sample onto the test system (the scanning module 60 transmits the time that the sample container 90 is gripped; paragraph 45).
Regarding claim 3, Olson teaches the method as claimed in claim 1, wherein the clotting wait time is determined based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraph 44);
b) a time of loading the blood sample in the container onto the test system (the scanning module 60 transmits the time that the sample container 90 is gripped; paragraph 45);
c) addition of at least one clotting agent to the blood sample and/or the container (the set period of time may differ based on the sample type, additive type and environmental conditions; paragraph 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (paragraph 47).
Regarding claim 4, Olson teaches the method as claimed in claim 3, wherein the at least one patient specific coagulation parameter is derived from at least one of an electronic medical record (EMR), a Laboratory Information System (LIS), a Hospital Information System (HIS), and any other Personal Health Information (PHI) (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25 and 41).
Regarding claim 5, Olson teaches the method as claimed in claim 1, further comprising monitoring the clotting wait time with a timer of the test system (the controller 80 is also configured to monitor the time that the sample container 90 is held in the rack 42 of the staging module 402; paragraph 40).
Regarding claim 6, Olson teaches the method as claimed in claim 1, further comprising
a) subjecting the container comprising the blood sample to a centrifugation step to segregate a serum from a residual clot (separate serum from whole blood via centrifugation; paragraph 26); and
b) providing the serum to at least one test station, the at least one test station being part of or connected to the test system, for further analysis, preferably wherein the test station is a blood serum analyzer (prepare samples for testing and analysis via a test analyzer; paragraph 21).
Regarding claim 7, Olson teaches the method as claimed in claim 3, wherein at least one clotting agent is comprised in or added to the blood sample, which is configured to reduce the clotting wait time for the blood sample (EDTA containers must be inverted 10 times after collection to ensure proper mixing between whole blood and the K2EDTA anticoagulant; paragraph 26).
Regarding claim 8, Olson teaches the method as claimed in claim 1, wherein the clotting wait time is entered (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47), received and/or provided via a user interface coupled to the test system (the use of a controller 80 including a processor 82 and memory 84 implies a computer with a keyboard for data entry; paragraph 22).
Regarding claim 9, Olson teaches method as claimed in claim 1, wherein the clotting wait time is selected, computed and/or determined automatically by the test system (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 10, Olson teaches the method as claimed in claim 3, wherein the clotting wait time is adjusted to be either longer than or shorter than a predefined default clotting wait time based on the at least one patient specific coagulation parameter (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time, and can be adjusted within certain ranges depending on various conditions (e.g., whether additives are added to the sample or not, or different clot activators); paragraphs 46 and 47).
Regarding claim 11, Olson teaches the method as claimed in claim 1, wherein the container is held in a vertical position during the clotting wait time, wherein a top of the container is either open or closed with a cap, a lid, a stopper, a film, or any other container closing structure (the sample container 90 includes a cap 98 that can close off the upper end 94 of the sample container 90; paragraph 24).
Regarding claim 12, Olson teaches method as claimed in claim 1, wherein the sample related data source is a unique identifier comprising at least one of a bar code, a MEMS, smart dust, an RFID chip or a NFC chip coupled to the container (the scanning module 60 is used to scan the identifier 99 of the sample container 90; paragraphs 25, 27, 46 and 47).
Regarding claim 13, Olson teaches a laboratory test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C) comprising:
a) a container storage (sample preparation module 20 and sample staging module 40) for storing at least one container (process sample containers 90) containing a blood sample (paragraph 24) for a duration of a clotting wait time (paragraphs 40, 41 and 47);
b) an automated sample conveyance system (e.g., actuator 126; paragraphs 34 – 39) coupled to one or more test stations (staging module 40; paragraph 47); and the conveyance system configured to convey the at least one container to at least one of the one or more test stations, and
c) a processor (controller 80; paragraphs 22 and 23) configured to:
i) set a clotting start time for the blood sample and/or the container (e.g., the set period of time is intended to match the clotting time; paragraph 47);
ii) set a clotting wait time to allow the blood sample to clot (the staging module 40 is configured to hold multiple sample containers 90 for a set period of time. Typically, the set period of time is sufficient to allow the blood in the sample container to further clot; paragraph 40); and
iii) on positive determination of completion of the clotting wait time, automatically providing the blood sample to a centrifuge coupled to the test system (centrifuge module 70; paragraphs 41 – 43);
wherein a time of a withdrawal of the blood sample into the container is obtained from a sample related data source (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47), and
wherein at least one statement from the following group of statements is true:
the clotting start time is set as the time of withdrawal of the blood sample into the container (paragraphs 44 and 47); and
the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (paragraphs 44 and 47).
Regarding claim 14, Olson teaches laboratory test system as claimed in claim 13, wherein the processor is
configured to set the clotting start time based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47); and
b) a time of loading the container containing the blood sample onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47).
Regarding claim 15, Olson teaches laboratory test system as claimed in claim 13, wherein the processor is configured to determine the clotting wait time based on at least one of:
a) the time of withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47);
b) a time of loading the blood sample in the container onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47);
c) addition of at least one clotting agent to the blood sample and/or the container (paragraph 47);
f) at least one patient specific coagulation parameter (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5 and 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 16, Olson teaches the laboratory test system as claimed in claim 15, wherein the at least one patient specific coagulation parameter is derived from at least one of an electronic medical record (EMR), a laboratory information system (LIS), a hospital information system (HIS), and any other personal health information (PHI) (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25 and 41).
Regarding claim 17, Olson teaches laboratory test system as claimed in claim 13, wherein the clotting wait time is entered, received and/or provided via a user interface coupled to the test system (the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 18, Olson teaches the laboratory test system as claimed in claim 13, wherein the clotting wait time is selected, computed and/or determined automatically by the test system (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Regarding claim 19, Olson teaches a computer-readable medium (paragraph 22; figure 8) comprising instructions which, when executed by a processor of a computing device (controller 80) associated with a test system (sample preparation device 10; paragraph 21; figures 1 – 3 and 5A – 5C), causes the test system to:
a) set a clotting start time for a blood sample and/or a container (e.g., the set period of time is intended to match the clotting time; paragraph 47), wherein the clotting start time is set as at least one of:
i) a time of a withdrawal of the blood sample into the container (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 25, 44 and 47); and
ii) a time of loading the container containing the blood sample onto the test system (a collection technician extracts blood and into sample container 90, then the scanning module 60 scans the identifier 99 on the sample container. The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44 and 47);
b) set a clotting wait time to allow the blood sample to clot (paragraphs 40 and 47); and
c) on positive determination of completion of the clotting wait time (paragraphs 40 and 47), automatically providing the blood sample to a centrifuge coupled to the test system (the staging module 40 can release the sample container to one of the storage compartments 19a, 19b or to the centrifugation module 70; paragraph 41); wherein the time of the withdrawal of the blood sample into the container is obtained from a sample related data source (The scanning module 90 transmits the time the sample container 90 is gripped and information, such as sample ID, to the controller 90; paragraphs 44, 46 and 47); and wherein at least one statement from the following group of statements is true:
i) the clotting start time is set as the time of withdrawal of the blood sample into the container (paragraphs 40, 41 and 47); and
ii) the clotting wait time is set based on at least the time of withdrawal of the blood sample into the container (paragraphs 40, 41 and 47).
Regarding claim 20, Olson teaches computer-readable medium as claimed in claim 19, wherein the processor is configured to determine the clotting wait time based on at least one of:
a) the time of withdrawal of the blood sample into the container (paragraphs 44 and 47);
b) a time of loading the blood sample in the container onto the test system (paragraphs 44 and 47);
c) addition of at least one clotting agent to the blood sample and/or the container (the set period of time may differ based on the sample type, additive type and environmental conditions; paragraph 41);
f) at least one patient specific coagulation parameter (the CLSI-GP44 standard is followed for sample handling, processing and preparation; paragraphs 4, 5, 25 and 41); and
g) a predefined clotting wait time, optionally as specified by the test system manufacturer (according to the CLSI-GP44 standard, the set period of time is intended to match the clotting time; paragraph 47).
Conclusion
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, Elizabeth A Robinson can be reached at (571) 272-7129. 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