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 .
Drawings
The drawings were received on 9/28/2023. These drawings are acceptable.
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.
Claim(s) 1-7 and 10-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cook et al (US 9,075,042 B2) (provided by applicant in IDS dated 9/28/2023).
With respect to claim 1 Cook discloses a method of operating a diagnostic instrument (a system and method of a clinical diagnostic system; See abstract, Fig. 1, Col. 13, lines 50-67), comprising:
providing a diagnostic instrument having one or more modules (a diagnostic system 10 having a plurality of modules; See Fig. 1 and Col. 13, lines 50-67), wherein the one or more modules are configured to analyze specimens (wherein the diagnostic system 10 comprises a plurality of modules including one for blood filtration and one for detection; See Fig. 1, Col. 13, line 50 – Col. 14, line 11; Col. 27, lines 24-44; Col. 39, lines 10-17);
providing a specimen sorter coupled to the diagnostic instrument (providing a blood collection tube 40 coupled to the diagnostic system 10 adapted to collect blood leaving the filtration module 19; See Col. 27, lines 24-67); and
sorting specimens into at least a first group and a second group using the specimen sorter (and sorting patients whole blood into blood and plasma groups using the filtration module 19 coupled to blood collection tube 40; See Col. 13, line 50 – Col. 14, line 11; Col 27, line 63 – Col. 28, line 11 ), wherein specimens in the first group are to be analyzed in at least one of the one or more modules (the plasma which is sorted into the plasma cache is sent further into the system for metering and analyzation; See Col. 27, line 63 – Col. 28, line 11 ), and specimens in the second group are not to be analyzed in any of the one or more modules (and the filtered concentrated whole blood is not analyzed and sent to the waste area for disposal; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 2 Cook discloses moving specimens in the first group to at least a first rack (the plasma which is sorted into the plasma cache (first rack) is sent further into the system for metering and analyzation; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 3 Cook discloses moving specimens in the second group to at least a second rack (and the filtered concentrated whole blood is not analyzed and sent to the waste area (second rack) for disposal; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 4 Cook discloses moving specimens in the second group to at least a second rack (and the filtered concentrated whole blood is not analyzed and sent to the waste area (second rack) for disposal; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 5 Cook discloses moving specimens in the second group to at least a second rack that is resident at the specimen sorter (and moving the filtered concentrated whole blood via the filtration module 19 is not analyzed and sent to the waste area (second rack) for disposal; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 6 Cook discloses providing the specimen sorter comprises providing a specimen sorter configured as one of the one or more modules (the specimen sorter provided as filtration module 19; See Col. 27, lines 24-62).
With respect to claim 7 Cook discloses receiving data from a location external to the diagnostic instrument (comprising receiving data from a bar code which is external to the diagnostic system 10; See Col. 27, lines 7-24), the data indicating whether at least one of the specimens is to be sorted into the first group or the second group (the bar code data indicating how many trials of plasma for the diagnostic tests to collect form the plasma cache after being sorted from plasma and whole red blood; See Col. 27, lines 7-62), wherein the sorting is in response to the data (wherein the amount of aliquot samples and the amount of samples prepared and the volume is determined by label data; See Col. 27, lines 7-62; also See Col. 29, lines 2-43).
With respect to claim 10 Cook discloses sorting specimens into a fourth group (aliquoting a sample into a plurality of volumes which would include up to a fourth group; See Col. 27, line 63 - Col. 28, line 40), specimens in the fourth group not requiring further analyses (some samples not requiring further analysis as waste; See Col. 28, lines 13-63).
With respect to claim 11 Cook discloses providing a reader coupled to the specimen sorter (a reader for reading the surface bar code of a blood collection tube coupled to the filtration module 19; See Col. 27, lines 16-62); and
reading information from a label of a specimen container containing a specimen (and reading data from the bar code present on the tuber containing a sample; See Col. 27, lines 16-62).
With respect to claim 12 Cook discloses that the sorting is performed at least partially in response to the reading (the sorting once the plasma has been collected into sample volumes for testing is controlled by data collected from the reader; See Col. 28, lines 13-64).
With respect to claim 13 Cook discloses providing a transport system interconnecting the specimen sorter and at least one of the one or more modules (providing cartridge body 18 as a transport system interconnecting the filtration module 19 and the detection module; See Fig. 6 and Col. 27, lines 7-63); and
moving specimens in the first group by way of the transport system (moving the plasma via the cartridge body 18 into the plasma cache; See Fig. 6 and Col. 27, lines 7- Col. 28, line 11).
With respect to claim 14 Cook discloses that the one or more modules are configured to determine a dule configured for precise and accurate concentration of at least one analyte in the specimens (a software module configured for precise and accurate concentration measurements; See Col. 38, lines 1-12).
With respect to claim 15 Cook discloses that the one or more modules are configured to determine a presence of at least one analyte in the specimens (the software module further configured to determine presence of a biomarker or analyte; See Abstract and Col. 38, lines 1-12).
With respect to claim 16 Cook discloses a method of operating a diagnostic instrument (a system and method of a clinical diagnostic system; abstract; figure 1; column 13, lines 50-67), comprising:
providing a diagnostic instrument having one or more modules (a diagnostic system 10 having a plurality of modules; See Fig. 1 and Col. 13, lines 50-67), wherein the one or more modules are configured to analyze and/or process specimen containers and/or specimens contained in specimen containers (wherein the diagnostic system 10 comprises a plurality of modules including one for blood filtration and one for detection; See Fig. 1 and Col. 13, line 50 – Col. 14, line 11; Col. 27, lines 24-44; Col. 39, lines 10-17);
providing a specimen sorter coupled to the diagnostic instrument (providing a blood
collection tube 40 coupled to the diagnostic system 10 adapted to collect blood leaving the filtration module 19; See Col. 27, lines 24-67); and
sorting specimen containers into at least a first group and a second group (and sorting patient’s whole blood into blood and plasma groups using the filtration module 19 coupled to blood collection tube 40; See Col. 13, line 50 – Col. 14, line 11; Col. 27, line 63 -
Col. 28, line 11), specimen containers or specimens in the first group to be analyzed or processed by at least one of the one or more modules (the plasma which is sorted into the plasma cache is sent further into the system for metering and analyzation; See Col. 27, line 63
- Col. 28, line 11), specimen containers or specimens in the second group not to be analyzed or processed by any of the one or more modules (and the filtered concentrated whole blood is not analyzed and sent to the waste area for disposal; See Col. 27, line 63 – Col. 28, line 11).
With respect to claim 17 Cook discloses that the one or more modules are configured to determine a concentration of at least one analyte in the specimens (a software module configured for precise and accurate concentration measurements; See Col. 38, lines 1-12).
With respect to claim 18 Cook discloses that the one or more modules are configured to determine a presence of at least one analyte in the specimens (the software module further configured to determine presence of a biomarker or analyte; See Abstract and Col. 38, lines 1-12).
With respect to claim 19 Cook discloses a diagnostic instrument (a system and method of a clinical diagnostic system; See Abstract, Fig. 1, Col. 13, lines 50-67), comprising:
one or more modules (a diagnostic system 1 0 having a plurality of modules; See Fig. 1 and Col. 13, lines 50-67);
a specimen sorter configured to sort specimens into at least a first group and a second group (a filtration module 19 configured to sort plasma and whole red blood; See Col. 27, lines 24-67), wherein specimens in the first group are to be analyzed by at least one of the
one or more modules (the plasma which is sorted into the plasma cache is sent further into the system for metering and analyzation; See Col. 27, line 63 – Col. 28, line 11), and specimens in the second group are not to be analyzed by any of the one or more modules (and the filtered concentrated whole blood is not analyzed and sent to the waste area for disposal; See Col. 27, line 63 – Col. 28, line 11); and
a transport system interconnecting the specimen sorter and at least one of the one or more modules (providing cartridge body 18 as a transport system interconnecting the filtration module 19 and the detection module; See Fig. 6 and Col. 27, lines 7-63), the transport system being configured to move specimens in the first group to at least one of the one or more modules (and moving the plasma via the cartridge body 18 into the plasma cache where it can be further moved to a detection module for analyzation; See Fig. 6 and Col. 27, lines 7 – Col. 28, line 11 ).
With respect to claim 20 Cook discloses that the transport system is configured to move
specimens in the second group from the diagnostic instrument (and the filtered concentrated whole blood is not analyzed and sent to the waste area for disposal; See Col. 27, line 63 – Col. 28, line 11).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al (US 9,075,042 B1) in view of Seligmann et al (US 2008/0268451 A1) (provided by applicant in IDS dated 9/28/2023).
Refer above for the disclosure of Cook.
With respect to claim 8 Cook fails to disclose receiving data from a laboratory
information system, the data indicating whether at least one of the specimens is to be sorted into the first group or the second group, wherein the sorting is in response to the data.
Seligmann teaches receiving data from a laboratory information system (receiving data from known genetic databases; See Para. 0065), the data indicating whether at least one of the specimens is to be sorted into the first group or the second group (the data selecting whether the sample matches that of a target RNA sample if it is a target sample it being extracted; See Paras. 0064-0066), wherein the sorting is in response to the data (wherein the sorting is in response to database information and the target of interest; See Para. 0065).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Cook to provide comprising receiving data from a laboratory information system, the data indicating whether at least one of the specimens is to be sorted into the first group or the second group, wherein the sorting is in response to the data, as taught by Seligmann, in order to provide database of known information to double check information in relation to target samples identified (See Para. 0065 of Seligmann).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al (US 9,075,042 B1) in view of Quistgaard et al (US 2003/0009102 A1) (provided by applicant in IDS dated 9/28/2023).
Refer above for the disclosure of Cook.
With respect to claim 9, although Cook discloses sorting specimens into a third group (aliquoting a sample into a plurality of volumes which would include up to a third group; See Col. 27, line 63 – Col. 28, line 40), Cook fails to disclose specimens in the third group to be analyzed by one or more modules external to the diagnostic instrument.
Quistgaard teaches that specimens in the third group are to be analyzed by one or more modules external to the diagnostic instrument (the third sample group would
be analyzed by an external hardware element such as a detachable scan head or ECG device which are external to the overall device unit 100; See Para. 0089).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Cook to provide specimens in the third group to be analyzed by one or more modules external to the diagnostic instrument, as
taught by Quistgaard, to provide the use of a specialized component when necessary and adding modularity to the overall device for use with multiple attachments (See Para. 0089 of Quistgaard).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 June 23, 2026
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